Effect of a fermented milk containing Bifidobacterium animalis DN‐173 010 on the health‐related quality of life and symptoms in irritable bowel syndrome in adults in primary care: a multicentre, randomized, double‐blind, controlled trial
Open accessAbstract
BACKGROUND: Health-related quality of life (HRQoL) has been rarely evaluated as a primary endpoint in the assessment of the effect of probiotics on the irritable bowel syndrome (IBS). AIM: To study the effects of fermented milk containing Bifidobacterium animalis DN-173 010 and yoghurt strains on the IBS in a multicentre, double-blind, controlled trial. METHODS: A total of 274 primary care adults with constipation-predominant IBS (Rome II) were randomized to consume for 6 weeks either the test fermented milk or a heat-treated yoghurt (control). HRQoL and digestive symptoms were assessed after 3 and 6 weeks on an intention-to-treat population of 267 subjects. RESULTS: The HRQoL discomfort score, the primary endpoint, improved (P < 0.001) in both groups at weeks 3 and 6. The responder rate for the HRQoL discomfort score was higher (65.2 vs. 47.7%, P < 0.005), as was the decrease in bloating score [0.56 +/- (s.d.)1.01 vs. 0.31 +/- 0.87, P = 0.03], at week 3 in the test vs. the control group. In those subjects with <3 stools/week, stool frequency increased (P < 0.001) over 6 weeks in the test vs. control group. CONCLUSIONS: This study suggests a beneficial effect of a probiotic food on discomfort HRQoL score and bloating in constipation-predominant IBS, and on stool frequency in subjects with <3 stools/week.
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Claims the paper makes
4 of 39 cited sources checked · 1 supported · 0 flagged · accuracy not yet measured
- Interpretationcitation
The discomfort dimension of the FDDQL questionnaire was able to capture the improvement in multiple IBS symptoms.
“The discomfort dimension of FDDQL, a validated questionnaire, 29 was able to capture the improvement in multiple IBS symptoms”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [29] 29. Chassany O, Marquis P, Scherrer B, et al. Validation of a specific quality of life questionnaire for functional diges- tive disorders. Gut 1999; 44: 527-533. source
- Premisecitation
In healthy adults and elderly subjects, a fermented milk containing Bifidobacterium animalis DN-173 010 alone or with yoghurt starters has been shown to decrease orofecal and/or colonic transit time.
“In healthy adults as well as elderly subjects, a fermented milk containing Bifidobacterium animalis DN-173 010 alone or in association with the yoghurt starters Lactobacillus bulgaricus and Streptococcus thermophilus has been shown to decrease orofecal and ⁄ or colonic, especially sigmoid, transit time; [22][23][24][25]”
Quote in the paperNot a substantial claim1 of 3 sources checked- cites [22] 22. Me ´ance S, Cayuela C, Turchet P, Raimondi A, Lucas C, Antoine JM. A fermented milk with a Bifidobacterium probiotic strain DN-173 010 shortened oro-fecal gut transit time in elderly. Microb Ecol Health Dis 2001; 13: 217- 222. source
- cites [23] 23. Me ´ance S, Cayuela C, Turchet P, Rai- mondi A, Lucas C, Antoine JM. Recent advances in the use of functional foods: effects of the commercial fermented milk with Bifidobacterium animalis strain DN-173 010 and yoghurt strains on gut transit time in the elderly. Mic- rob Ecol Health Dis 2003; 15: 15-22. source
- cites [24] 24. Marteau P, Cuillerier E, Me ´ance S, et al. Bifidobacterium animalis strain DN-173 010 shortens the colonic transit time in healthy women: A double blind rand- omised controlled study. Aliment Phar- macol Ther 2002; 16: 587-593. source
The Discussion (p. 5) reports shorter total colonic and sigmoid transit times in healthy women who consumed fermented milk containing B. animalis DN-173 010 plus yoghurt cultures. This paper does not establish the claim for elderly subjects, orofecal transit time, or milk containing the strain without yoghurt cultures. (LLM, conf=0.88)
Experimental — accuracy not yet measured
- Premisecitation
A clear-cut effect of probiotics on constipation per se has rarely been shown in IBS subjects, except in two studies.
“A clear-cut effect of probiotics on constipation per se has been quite rarely shown in IBS subjects, except in two studies.17,64”
Quote in the paperNot a substantial claim1 of 2 sources checked- cites [17] 17. Whorwell PJ, Altringer L, Morel J, et al. Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 2006; 101: 1581- 1590. source
- cites [64] 64. Koebnick C, Wagner I, Leitzmann P, Stern U, Zunft HJ. Probiotic beverage containing Lactobacillus casei Shirota improves gastrointestinal symptoms in patients with chronic constipation. Can J Gastroenterol 2003; 17: 655-659. source
The Results report improved constipation symptoms with the probiotic, and the Introduction says only a few studies had examined probiotics for constipation. But Patients and Methods describes participants with chronic idiopathic constipation, not an identified IBS population; the paper also does not establish that exactly two studies showed a clear-cut effect in IBS subjects. (LLM, conf=0.87)
Experimental — accuracy not yet measured
- Findingown data
The stress impact dimension was more improved at week 6 in the control group than in the test product group.
“The stress impact dimension was more (P < 0.05) improved, at week 6, in the control as compared to the test product group.”
Quote in the paperNot a substantial claim - Findingown data
An increasing placebo effect was observed in the control group from week 3 to week 6.
“Moreover, we observed an increasing placebo effect in the control group from week 3 to week 6, which may account for the non-significant effect of test product on bloating and responder rate for discomfort dimension of FDDQL at week 6.”
Quote in the paperSubstantial claim
- Findingown data
The improvement in bloating score was significantly higher at week 3 in the test product group.
“The improvement in bloating score was significantly (P = 0.03) higher at week 3 in the test Changes from baseline”
Quote in the paperNot a substantial claim - Findingown data
Score changes at weeks 3 and 6 compared with baseline for the diet, sleep, health perception and coping with disease dimensions, and the global score, did not differ significantly between groups.
“Score changes, at weeks 3 and 6 vs. baseline, of diet, sleep, health perception and coping with disease dimensions, and the global score did not differ significantly between groups (Table 3).”
Quote in the paperNot a substantial claim - Findingown data
The between-group effect size for the discomfort dimension at week 3 was 0.22 in favour of the test group.
“The effect size between groups at week 3 is 0.22 in favour of the test group.”
Quote in the paperNot a substantial claim - Findingown data
The percentage of responders for the discomfort dimension was significantly higher at week 3 in the test product group than in the control group (65.2 vs. 47.7%, P = 0.003).
“The percentage of responders for the discomfort dimension was significantly higher (65.2 vs. 47.7%,P = 0.003) at week 3, in the test product as compared to the control group.”
Quote in the paperSubstantial claim - Findingown data
A high placebo effect was observed in the control group in the present study.
“A high ''placebo'' effect was observed in the control group in the present work, which confirms well-known data reported in IBS placebo-controlled trials showing an average placebo response rate of 40-45%.”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [45] 45. Enck P, Klosterhalfen S. The placebo response in functional bowel disorders: perspectives and putative mechanisms. Neurogastroenterol Motil 2005; 17: 325-331. source
- cites [46] 46. Pitz M, Cheang M, Bernstein CN. Defi- ning the predictors of the placebo response in irritable bowel syndrome. Clin Gastroenterol Hepatol 2005; 3: 237-247. source
- Findingown data
Bloating and abdominal pain scores at weeks 3 and 6 significantly improved compared with baseline within both groups.
“Bloating and abdominal pain scores at weeks 3 and 6 significantly (P < 0.001) improved as compared to baseline within both groups.”
Quote in the paperNot a substantial claim - Findingown data
In the subgroup with <3 stools per week, the test probiotic product produced a mean increase of up to 6 stools per week.
“a striking and significant effect (up to a mean of 6 stools per week) of the test probiotic product on stool frequency was observed in that subgroup of subjects with the quantitatively most severe (<3 stools per week) degree of constipation”
Quote in the paperSubstantial claim - Findingown data
The test probiotic product increased stool frequency in subjects with <3 stools per week.
“In conclusion, the present large-scale study strongly suggests a beneficial effect of a probiotic food containing B. animalis DN-173010 on HRQoL discomfort score and bloating, and also on stool frequency in those subjects with <3 stools per week.”
- Also stated in: § DISCUSSION · boosted
“a striking and significant effect (up to a mean of 6 stools per week) of the test probiotic product on stool frequency was observed in that subgroup of subjects with the quantitatively most severe (<3 stools per week) degree of constipation”
Quote in the paperSubstantial claim - Also stated in: § DISCUSSION · boosted
- Findingcitation
Most of the present primary care IBS subjects had mild-to-moderate constipation, defined more often by hard/lumpy stools and/or straining than solely by <3 bowel motions per week.
“Most of the present primary care IBS subjects had mild-to-moderate constipation (which was defined, according to Rome II criteria, 7 more often by hard ⁄ lumpy stools and ⁄ or straining than solely by <3 bowel motions per week)”
Quote in the paperNot a substantial claim - Findingown data
The increase in stool frequency in the subgroup with <3 stools per week was unaccompanied by a significant change in stool consistency scores.
“The increase in stool frequency, unaccompanied by a significant change in stool consistency scores, showed a rapid onset, i.e. after 1 week of product consumption, and was sustained throughout the 6-week study.”
Quote in the paperNot a substantial claim - Study design and conductown data
Baseline characteristics showed no significant differences between the test product and control groups.
“They showed no significant differences between the test product and control groups (Table 1).”
Quote in the paperNot a substantial claim - Interpretationreasoning
The high placebo effect may have led to an underestimate of the observed effect of the test product.
“Consequently, this may have led to an underestimate of the observed effect of the test product.”
Quote in the paperNot a substantial claim - Interpretationown data
The increasing placebo effect in the control group may account for the non-significant effect of the test product on bloating and responder rate for the discomfort dimension at week 6.
“Moreover, we observed an increasing placebo effect in the control group from week 3 to week 6, which may account for the non-significant effect of test product on bloating and responder rate for discomfort dimension of FDDQL at week 6.”
Quote in the paperNot a substantial claim - Study design and conductown data
The trial sample size was calculated to give 85% power to detect a between-group effect size of 0.4 for the primary endpoint, requiring at least 114 subjects per treatment group.
“The trial sample size, required to give a power of 85% for detecting a 'between group' effect size of 0.4 for the primary endpoint, was calculated to be at least 114 subjects per treatment group.”
Quote in the paperSubstantial claim - Premisecitation
In clinical trials on IBS, the initial degree of symptom severity is a key point because it may influence improvement of symptoms and HRQoL.
“In clinical trials on IBS, the initial degree of symptom severity is a key point, since it may influence the improvement of these symptoms and HRQoL; 44”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [44] 44. Withehead WE, Palsson OS, Levy RL, Feld AD, VonKorff M, Turner M. Reports of ''satisfactory relief'' by IBS patients receiving usual medical care are con- founded by baseline symptom severity and do not accurately reflect symptom improvement. Am J Gastroenterol 2006; 101: 1057-1065. source
- Premisecitation
The great majority of clinical trials on probiotics in IBS over past years had methodological weaknesses, particularly small numbers of study subjects, most often <35 per group.
“Unfortunately, even if the use of probiotics seems to be very promising, the very great majority of clinical trials on probiotics in IBS over the past years had methodological weaknesses, particularly due to the small number of study subjects, i.e. most often <35 per group.20,21”
Quote in the paperSubstantial claim0 of 2 sources checked - Premisecitation
The positive effects on bloating reported with non-absorbable antibiotics support the role of the enteric microbiota in IBS.
“The positive effects on bloating also reported with non-absorbable antibiotics 62 further supports the evolving role of the enteric microbiota in IBS.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [62] 62. Sharara AI, Aoun E, Abdul-Baki H, Mounzer R, Sidani S, Elhajj I. A rand- omized double-blind placebo-controlled trial of rifaximin in patients with abdominal bloating and flatulence. Am J Gastroenterol 2006; 101: 326-333. source
- Interpretationreasoning
The small number of subjects in the <3 stools/week subgroup is probably accounted for by the mild-to-moderate constipation of most subjects.
“that probably accounts for the relatively small number of subjects in the abovementioned subgroup.”
Quote in the paperNot a substantial claim
- Classified as probably not a substantial claim. 19
- May combine two claims. 23
- The quote only partly states this claim. 3
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationA similar alleviating effect on bloating of VSL#3 and Bifidobacterium infantis 35624 has been reported in IBS study populations of 35 and 77 subjects, respectively.
“A similar alleviating effect on bloating of VSL#3, 55 a mixture of 8 probiotics, and of B. infantis 35624 16 has been reported in a study population of IBS subjects (35 and 77 subjects, respectively).”
Quote in the paperNot a substantial claim1 of 2 sources checked- cites [55] 55. Kim HJ, Camilleri M, McKinzie S, et al. A randomized controlled trial of a pro- biotic, VSL#3, on gut transit and symp- toms in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther 2003; 17: 895-904. source
The Discussion reports that VSL#3 appeared to reduce bloating in diarrhoea-predominant IBS, although the between-group difference was only borderline significant (Other symptom assessments; P = 0.09). The Demographic characteristics section says 25 patients were randomized, not 35. The separately cited B. infantis study and its 77 subjects are not attributed to this source. (LLM, conf=0.90)
Experimental — accuracy not yet measured - cites [16] 16. O'Mahony L, McCarthy J, Kelly P, et al. Lactobacillus and Bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology 2005; 128: 541-551. source
May combine two claims.
Findingown dataDaily activities and anxiety scores improved at weeks 3 and 6 compared with baseline in both groups, and the improvement was significantly higher in the control group than in the test product group.
“The scores of daily activities and anxiety improved (P < 0.001) at weeks 3 and 6, as compared to baseline, in both groups; the improvement was significantly higher in the control vs. the test product group (Table 3).”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataThe test product exhibited a difference over the control group of 17.5% in the rate of responders for the HRQoL discomfort score, resulting in a number needed to treat of 5.7.
“However, in spite of this, the test product exhibited a difference over the control group of 17.5% in the rate of responders for HRQoL discomfort score, which in turn results in a number needed to treat of 5.7.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataIn the ITT population (n = 267), stool frequency and consistency did not differ between the test product and control groups.
“In the ITT population (n = 267), stool frequency (Figure 2a) and consistency (data not shown) did not differ between the test product and control groups.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataIn the present study, a significant relief in abdominal bloating was observed for the whole probiotic subject group and for the subgroup characterized by a stool frequency of <3 stools per week.
“In the present study, we observed a significant relief in abdominal bloating, for the whole probiotic subject group and for the subgroup characterized by a stool frequency of <3 stools ⁄ week.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataTen control subjects and 13 test product subjects reported minor adverse events; 4 control subjects and 3 test subjects stopped product consumption after an adverse event; 2 control subjects reported serious adverse events.
“Ten subjects from the control group and 13 from the test product group reported minor adverse events throughout the study.Four subjects in the control group and three in the test group stopped the consumption of the product after an adverse event.Two subjects reported serious adverse events in the control group.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataIn the subgroup of constipated IBS subjects (n = 19), HRQoL discomfort score and responder rate, bloating, abdominal pain and global digestive symptom scores improved at week 6 in the test product subgroup but not in the control subgroup.
“HRQoL discomfort score and responder rate, bloating, abdominal pain and global digestive symptom scores improved (P < 0.05) at week 6 in the test product but not in the control subgroup.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataIn the subgroup of constipated IBS subjects (n = 19, defined by <3 bowel movements per week), stool frequency increased over the 6-week period, with effect as soon as week 1, in the test product subgroup compared with the control subgroup.
“In the subgroup (n = 19) of constipated IBS subjects, defined on the basis of <3 bowel movements per week, stool frequency increased (P < 0.001) over the 6-week period of product consumption, showing effect as soon as week 1, in the test product subgroup as compared to the control subgroup (Figure 2b).”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataThe discomfort dimension score improved at weeks 3 and 6 compared with baseline in both groups, but the improvement did not significantly differ between groups.
“Discomfort dimension score, the primary HRQoL endpoint, improved (P < 0.001) at weeks 3 and 6, as compared to baseline, in both groups but the improvement did not significantly differ between groups (Table 2).”
Quote in the paperSubstantial claimThe quote only partly states this claim.
Findingown dataThe test probiotic product improved health-related quality of life (HRQoL) discomfort score in the intention-to-treat population.
“In conclusion, the present large-scale study strongly suggests a beneficial effect of a probiotic food containing B. animalis DN-173010 on HRQoL discomfort score and bloating, and also on stool frequency in those subjects with <3 stools per week.”
Quote in the paperSubstantial claimMay combine two claims. The quote only partly states this claim.
Findingown dataThe increase in stool frequency in the subgroup with <3 stools per week had a rapid onset after 1 week of product consumption and was sustained throughout the 6-week study.
“The increase in stool frequency, unaccompanied by a significant change in stool consistency scores, showed a rapid onset, i.e. after 1 week of product consumption, and was sustained throughout the 6-week study.”
Quote in the paperNot a substantial claimThe quote only partly states this claim.
Findingown dataThe test probiotic product reduced bloating in the intention-to-treat population.
“In conclusion, the present large-scale study strongly suggests a beneficial effect of a probiotic food containing B. animalis DN-173010 on HRQoL discomfort score and bloating, and also on stool frequency in those subjects with <3 stools per week.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataIn the subgroup with <3 stools per week, the test probiotic product significantly alleviated bloating and global digestive symptom score.
“It is noteworthy that the favourable probiotic effects in this subgroup also included a significant alleviation of bloating and global digestive symptom score.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationAnalyses in the subgroup of definitely constipated subjects (n = 19, defined by <3 stools per week) applied a lower significance level of P < 0.001, as recommended.
“In addition, analyses of HRQoL, IBS symptoms and stool characteristics data were performed in the subgroup of those definitely constipated subjects (n = 19), as defined on the only basis of <3 stools per week; a lower significance level (P < 0.001) was applied for judging results in this subgroup, as recommended.36”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [36] 36. Lagakos SW. The challenge of subgroup analyses : reporting without distorting. N Engl J Med 2006; 354: 1667-1669. source
May combine two claims.
Study design and conductown dataSelf-reported product consumption levels were 96.3 ± 9.3% in the test product group and 96.7 ± 6.1% in the control group.
“The self-reported levels of product consumption were 96.3 Æ 9.3% and 96.7 Æ 6.1% in the test product and control groups, respectively.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataFrom 276 enrolled subjects, 274 were randomized; 7 were subsequently excluded, leaving 135 in the test product group and 132 in the control group, giving an ITT population of 267.
“From the 276 enrolled subjects, 274 were randomized.Seven subjects were subsequently excluded (premature withdrawal) leaving 135 subjects assigned to the test product group and 132 to the control group giving an ITT population of 267.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
InterpretationcitationThe significant reduction of bloating score appears to be of special interest because the magnitude of symptom reduction by standard medical care has been shown to be significantly greater in subjects with severe IBS than in those with moderate or mild IBS.
“The significant reduction of bloating score we observed appears to be of special interest, as the magnitude of symptom reduction by standard medical care has been shown to be significantly greater in subjects with severe IBS as compared to subjects with moderate or mild IBS.44”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [44] 44. Withehead WE, Palsson OS, Levy RL, Feld AD, VonKorff M, Turner M. Reports of ''satisfactory relief'' by IBS patients receiving usual medical care are con- founded by baseline symptom severity and do not accurately reflect symptom improvement. Am J Gastroenterol 2006; 101: 1057-1065. source
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationThe FDDQL questionnaire used to assess HRQoL was developed and validated by Chassany et al.
“This was assessed by the self-administration of the FDDQL questionnaire as developed and validated by Chassany et al., 29”
- Also stated in: § DISCUSSION · plain
“The discomfort dimension of FDDQL, a validated questionnaire, 29”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Chassany et al., 29
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Also stated in: § DISCUSSION · plain
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductreasoning138 subjects per group were recruited to account for premature withdrawals and missing values for main criteria.
“To achieve a number of 114 subjects per group, 138 subjects per group were finally recruited to take into account premature withdrawals and missing values for main criteria.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Study design and conductnone givenAll analyses were done on the intention-to-treat population, defined as subjects having consumed at least one pot of product.
“All analyses were done on the intention-to-treat (ITT) population corresponding to subjects having consumed at least one pot of product.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Study design and conductreasoningThe primary endpoint was prespecified in the protocol as the discomfort HRQoL dimension at week 3.
“The primary endpoint as prespecified in the protocol was the discomfort HRQoL dimension that measures the problem impact of the whole IBS symptoms on HRQoL at week 3.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationTo the best of the authors' knowledge, only two studies reporting the effects of probiotics in IBS have used a specific IBS HRQoL questionnaire.
“To the best of our knowledge, only two studies 16,17 reporting the effects of probiotics in IBS have used a specific IBS HRQoL questionnaire: this is in line with the limited number of subjects in most of the previously published trials on the probiotics-IBS topic.”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [16] 16. O'Mahony L, McCarthy J, Kelly P, et al. Lactobacillus and Bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology 2005; 128: 541-551. source
- cites [17] 17. Whorwell PJ, Altringer L, Morel J, et al. Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 2006; 101: 1581- 1590. source
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationA Cochrane systematic review of antispasmodic agents in IBS yielded a number needed to treat of 6.
“A Cochrane systematic review of antispasmodic agents in IBS yielded a number needed to treat of 6. 52”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [52] 52. Quartero AO, Meineche-Schmidt V, Muris J, Rubin G, de Wit N. Bulking agents, antispasmodic and antidepres- sant medication for the treatment of irritable bowel syndrome. Cochrane Database Syst Rev 2005; 2: CD003460. source
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationAlthough IBS is not life-threatening, health-related quality of life is impaired in IBS.
“Although IBS is not a lifethreatening disease, health-related quality of life (HRQoL) is impaired.[10][11][12][13]”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [10] 10. Amouretti M, Le Pen C, Gaudin AF, et al. Impact of irritable bowel syn- drome (IBS) on health-related quality of life (HRQOL). Gastroenterol Clin Biol 2006; 30: 241-246. source
- cites [11] 11. ten Berg MJ, Goettsch WG, van den BG, Smout AJ, Herings RM. Quality of life of patients with irritable bowel syn- drome is low compared to others with chronic diseases. Eur J Gastroenterol Hepatol 2006; 18: 475-481. source
- cites [12] 12. Gralnek IM, Hays RD, Kilbourne A, Naliboff B, Mayer EA. The impact of irritable bowel syndrome on health-rela- ted quality of life. Gastroenterology 2000; 119: 654-660. source
May combine two claims.
PremisecitationHRQoL goes beyond symptoms and functional status and measures broader concepts, so expected improvement over time and expected between-group differences for HRQoL are smaller than those expected for symptoms.
“HRQoL goes beyond symptoms and functional status and thus measures broader concepts; therefore it is quite logical that the expected improvement over time and the expected differences between groups of the HRQoL endpoint are smaller than the ones expected for symptoms.39”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [39] 39. Corazziari E, Bytzer P, Delvaux M, et al. Clinical trial guidelines for pharmacolo- gical treatment of irritable bowel syn- drome. Aliment Pharmacol Ther 2003; 18: 569-580. source
May combine two claims.
PremisecitationSome probiotic strains have been associated with significant alleviation of IBS symptoms, while others proved ineffective.
“Some probiotic strains, either single (Bifidobacterium Infantis 36524, Lactobacillus Plantarum 299v) or combined (VSL#3), have been associated with a significant alleviation of IBS symptoms, [14][15][16][17] while others proved ineffective.[18][19][20]”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [14] 14. Nobaek S, Johansson ML, Molin G, Ahrne S, Jeppsson B. Alteration of intestinal microflora is associated with reduction in abdominal bloating and pain in patients with irritable bowel syndrome. Am J Gastroenterol 2000; 95: 1231-1238. source
- cites [15] 15. Kim HJ, Vazquez Roque MI, Camilleri M, et al. A randomized controlled trial of a probiotic combination VSL# 3 and placebo in irritable bowel syndrome with bloating. Neurogastroenterol Motil 2005; 17: 687-696. source
- cites [16] 16. O'Mahony L, McCarthy J, Kelly P, et al. Lactobacillus and Bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology 2005; 128: 541-551. source
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationOne study with alosetron reported a significant improvement of HRQoL, showing the sensitivity of HRQoL instruments to detect positive effects in trials.
“Indeed, one study with alosetron has reported a significant improvement of HRQoL, clearly showing the sensitivity of HRQoL instruments to detect positive effects in trials.43”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [43] 43. Watson ME, Lacey L, Kong S, et al. Alosetron improves quality of life in women with diarrhoea-predominant irritable bowel syndrome. Am J Gast- roenterol 2001; 96: 455-459. source
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationBloating is the most common abdominal complaint in IBS subjects, reported by 96% and considered the most bothersome symptom by 60% of them.
“Bloating, a supportive symptom of IBS diagnosis and a functional bowel disorder per se in the Rome II 7 and the very recent Rome III classifications, 8 is the most common abdominal complaint in IBS subjects, being reported and considered as the most bothersome symptom by 96% and 60% of them respectively. 9”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [9] 9. Azpiroz F, Malagelada JR. Abdominal bloating. Gastroenterology 2005; 129: 1060-1078. source
May combine two claims.
PremisecitationBifidobacterium animalis DN-173 010 survives complete transit through the digestive tract and is recovered live in stools in large quantities relative to the quantity initially ingested.
“B. animalis DN-173 010 survives complete transit through the digestive tract and is recovered live in stools in large quantities relative to the quantity initially ingested.[26][27][28]”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [26] 26. Berrada N, Lemeland JF, Laroche G, Thouvenot P, Piaia M. Bifidobacterium from fermented milks: Survival during gastric transit. J Dairy Sci 1991; 74: 409-413. source
- cites [27] 27. Pochart P, Marteau P, Bouhnik Y, God- erel I, Bourlioux P, Rambaud JC. Survi- val of Bifidobacteria ingested via fermented milk during their passage through the human small intestine: an in vivo study using intestinal perfusion. Am J Clin Nutr 1992; 55: 78-80. source
- cites [28] 28. Duez H, Pelletier C, Cools S, et al. A colony-immunobloting method for quantitative detection of a Bifidobacte- rium animalis probiotic strain in human faeces. J Appl Microbiol 2000; 88: 1019-1027. source
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationSubjects with mild symptoms are most likely to report satisfactory relief but showed no average decrease in symptom severity or improvement in IBS-QoL, while subjects with severe symptoms had the largest reductions in IBS symptom severity and largest improvements in IBS-QoL but were least likely to report satisfactory relief.
“although subjects with mild symptoms are the most likely to report satisfactory relief, they showed, in a recent study, no average decrease in symptom severity or improvement in IBS-QoL, while, conversely, subjects with severe-symptoms had the largest reductions in IBS symptom severity and the largest improvements in IBS-QoL but were the least likely to report satisfactory relief.44”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [44] 44. Withehead WE, Palsson OS, Levy RL, Feld AD, VonKorff M, Turner M. Reports of ''satisfactory relief'' by IBS patients receiving usual medical care are con- founded by baseline symptom severity and do not accurately reflect symptom improvement. Am J Gastroenterol 2006; 101: 1057-1065. source
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationBifidobacterium infantis 36524 proved capable in a large-scale trial on 362 primary care female subjects to alleviate major symptoms of IBS, with an associated anti-inflammatory effect.
“After a pilot study in a total of 80 male ⁄ female IBS subjects, 16 B. infantis 36524 proved capable in a large-scale trial on 362 (90 per group) primary care female subjects 17 to alleviate major symptoms of IBS, a clinical effect associated with an anti-inflammatory one as suggested by the correction of an abnormal interleukin (IL) 10 ⁄ IL12 blood ratio.16”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [16] 16. O'Mahony L, McCarthy J, Kelly P, et al. Lactobacillus and Bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology 2005; 128: 541-551. source
- cites [17] 17. Whorwell PJ, Altringer L, Morel J, et al. Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 2006; 101: 1581- 1590. source
Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.
PremisecitationThe alleviating effect of B. infantis 35624 has been confirmed and extended in a large randomized controlled trial.
“The alleviating effect of the latter probiotic has been very recently confirmed and extended, in a large randomized controlled trial.17”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [17] 17. Whorwell PJ, Altringer L, Morel J, et al. Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 2006; 101: 1581- 1590. source
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationB. infantis 35624 previously showed no effect on stool frequency in a more limited number of subjects.
“a probiotic which previously showed no effect on stool frequency in a more limited number of subjects.16”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [16] 16. O'Mahony L, McCarthy J, Kelly P, et al. Lactobacillus and Bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology 2005; 128: 541-551. source
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe probiotics tested in the present study may accelerate intestinal transit, especially colonic and sigmoid.
“Consistent with our observation is the previous finding that the probiotics tested in the present study may accelerate the intestinal, especially colonic and sigmoid, speed of transit.[22][23][24][25]”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [22][23][24][25]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenThe sample size was not calculated for the multiple comparisons done.
“even though the sample size was not calculated for the multiple comparisons done”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationThe study by Whorwell et al. concerned 362 primary care subjects with any bowel habit subtype who received B. infantis 35624 for 4 weeks.
“The most important one 17 concerned 362 primary care subjects with any bowel habit subtype having received for 4 weeks B. infantis 35624”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [17] 17. Whorwell PJ, Altringer L, Morel J, et al. Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 2006; 101: 1581- 1590. source
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Another study of the same probiotic reported a significant improvement from baseline in the probiotic group, but not in the placebo group, in a subanalysis of patients with fewer than three bowel movements/week.
“and another study of the same probiotic reported a significant improvement from baseline in the probiotic group, but not in the placebo group, in a subanalysis of patients with fewer than three bowel movements/week.36”
From Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice - an evidence-based international guide (2013) · cites this paper as [36]
Twelve studies evaluated abdominal pain as a secondary end point only, with mixed results: one reported a negative effect, eight reported no significant effect, and three reported a significant beneficial effect.
“Twelve studies evaluated abdominal pain as a secondary end point only. Results from these studies were mixed: one reported a negative effect of the specific probiotic treatment,59 eight (examining six different probiotics) reported no significant effect28–38 and three reported a significant beneficial effect of three different probiotics35,39”
From Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice - an evidence-based international guide (2013) · cites this paper as [36]
All three studies that examined flatus as a primary end point, and four of seven studies in which flatus was a secondary end point only, showed no significant difference between seven specific probiotic treatments and control.
“all three studies that examined flatus as a primary end point,30,57 and four of seven studies in which flatus was a secondary end point only,28–38 showed no significant difference between seven specific probiotic treatments and control.”
From Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice - an evidence-based international guide (2013) · cites this paper as [36]
Two studies reported no difference between specific probiotic treatments and placebo, and one study reported a significant worsening of diarrhoea with the specific probiotic treatment compared with placebo.
“Two studies reported no difference between specific probiotic treatments and placebo,28–37 and one study reported a significant worsening of diarrhoea with the specific probiotic treatment compared with placebo.59”
From Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice - an evidence-based international guide (2013) · cites this paper as [36]
Two studies evaluated overall IBS symptoms as a secondary end point only, and both reported a significant beneficial effect of the specific probiotic treatments in patients with IBS-D.
“Two studies evaluated overall IBS symptoms as a secondary end point only, and both reported a significant beneficial effect of the specific probiotic treatments33–39”
From Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice - an evidence-based international guide (2013) · cites this paper as [36]
One study in patients with IBS-C reported no significant difference between the probiotic and placebo groups for the change from baseline in the discomfort dimension score of the FDDQL questionnaire, but the probiotic group had a significantly greater proportion of responders for the discomfort dimension score than the placebo group at week 3.
“One study in patients with IBS-C36 reported no significant difference between the probiotic and placebo groups for the change from baseline in the discomfort dimension score of the Functional Digestive Disorders Quality of Life (FDDQL) questionnaire (primary end point); however, the probiotic group had a significantly greater proportion of responders for the discomfort dimension score than the”
From Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice - an evidence-based international guide (2013) · cites this paper as [36]
Probiotic effects on bloating are inconsistent, though certain strains-B. lactis DN-173118, Bifidobacterium animalis DN-173 010, and VSL#3-have shown benefit in some IBS studies.
“Efficacy of probiotic administration for symptoms of bloating have been less consistently reported153 although some studies in IBS patients have suggested benefit with specific probiotic strains including B. lactis DN-173118, Bifidobacterium animalis DN-173 010154, and VSL#3155.”
From The gut Microbiome in adult and pediatric functional gastrointestinal disorders (2019) · cites this paper as [154]
Trials of other probiotics (Propionibacterium, VSL#3, or fermented milk) did not show a positive effect on transit time.
“Several other clinical trials have investigated the effect of either probiotic strain(s) alone, i.e.Propionibacterium (34) and VSL#3 (35) or FM (36,37) and have failed to demonstrate a positive effect on transit time.”
A multicenter randomized double-blind controlled trial of B. animalis DN-173 010 reported improved health-related quality of life in constipation-predominant IBS.
“These findings are supported by a multicenter, randomized, double-blind, controlled trial using Bifidobacterium animalis, strain DN-173 010. This trial reported an improved health-related quality of life score in patients with constipation-predominant IBS.32”
From Probiotics and the gut microbiota in intestinal health and disease (2010) · cites this paper as [32]
Other smaller studies reported some beneficial effects with other probiotic strains including Bifidobacterium animalis DN-173 010, Bifidobacterium bifidum MIMBb75, Lactobacillus plantarum 299V, Saccharomyces boulardii, combination of Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07, and multispecies probiotic mixtures.
“Other smaller studies reported some beneficial effects with other probiotic strains including Bifidobacterium animalis DN-173 010 (74), Bifidobacterium bifidum MIMBb75 (72), Lactobacillus plantarum 299V (117), Saccharomyces boulardii (37), and combination of Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 (144) and multispecies probiotic mixtures (71, 87, 88).”
From Intestinal microbiota and immune function in the pathogenesis of irritable bowel syndrome (2013) · cites this paper as [74]
Products containing B. lactis DN-173 010 significantly increase evacuation frequency compared to control in randomized studies.
“Two randomized studies using products containing Bifidobacterium lactis DN-173 010 showed a significant increase in the frequency of evacuation when compared to the control group [13,14].”
B. lactis DN-173 010 improves bowel function in constipated subjects with Irritable Bowel Syndrome after six weeks.
“A study by Guyonet and co-workers [14] showed an improvement in bowel function in constipated subjects with Irritable Bowel Syndrome after the use of the same B. lactis for six weeks.”
Daily consumption of fermented milk containing B. lactis DN-173010 with yogurt starters alleviates bloating and improves digestive comfort in IBS constipation-predominant subjects, as assessed by the Functional Digestive Disorders Quality of Life questionnaire.
“This large scale (267 IBS constipation predominant, Rome II criteria), double-blind, randomized, controlled, parallel group study over 6 wk demonstrated that daily consumption of this product alleviates bloating and improves digestive comfort as assessed by the Functional Digestive Disorders Quality of Life questionnaire.”
From Effect of a fermented milk containing Bifidobacterium lactis DN-173010 on Chinese constipated women (2008) · cites this paper as [18]
Daily consumption of this product increases stool frequency in IBS subjects with the lowest stool frequency (<3 or 4 bowel movements/wk) without changing stool consistency.
“An increase in stool frequency was also observed in subjects with the lowest stool frequency (< 3 or 4 bowel movements/wk) without any change of stool consistency.”
From Effect of a fermented milk containing Bifidobacterium lactis DN-173010 on Chinese constipated women (2008) · cites this paper as [18]
Specific probiotics help relieve overall symptom burden in some patients with IBS, with high grade of evidence.
“Specific probiotics help relieve overall symptom burden in some patients with IBS High [147,149,150,152,156-157,169, 174,176-178]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [157]
Specific probiotics help relieve overall symptom burden in some patients with C-IBS, with low grade of evidence.
“Specific probiotics help relieve overall symptom burden in some patients with C-IBS Low [147,156-157]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [157]
Bifidobacterium strains reduced bloating in irritable bowel syndrome in probiotic intervention trials.
“In addition, probiotic intervention trials showed that Bifidobacterium strains reduced bloating in irritable bowel syndrome.”
From Adaptation to tolerate high doses of arabinoxylan is associated with fecal levels of <i>Bifidobacterium longum</i> (2024) · cites this paper as [60]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Probiotic strain number differs from the cited trial
MinorThe text identifies the strain in the large trial as 36524, while its cited reference identifies it as 35624.
“B. infantis 36524 proved capable in a large-scale trial on 362 (90 per group) primary care female subjects 17”
“17. Whorwell PJ, Altringer L, Morel J, et al. Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome.”
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- Authors
- GUYONNET, D., CHASSANY, O., DUCROTTE, P., PICARD, C., MOURET, M., MERCIER, C. ‐., & MATUCHANSKY, C.
- Affiliations
- Danone (France) (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Centre Hospitalier Universitaire de Rouen (FR)
- Université Paris Diderot (FR)
- Corresponding author
- GUYONNET, D.
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2007-05-04
- Volume
- 26
- Issue
- 3
- Pages
- 475-486
- ISSN
- 0269-2813 (ISSN-L)
- 1365-2036
- OpenAlex
- W2149809125
- Cited by
- 365
- References
- 68
- Citations by year
- 2026: 5 · 2025: 7 · 2024: 15 · 2023: 11 · 2022: 10 · 2021: 15 · 2020: 14 · 2019: 19 · 2018: 25 · 2017: 18 · 2016: 23 · 2015: 14 · 2014: 18 · 2013: 27 · 2012: 27
- FWCI
- 17.08
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Alimentary Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- HAL (Le Centre pour la Communication Scientifique Directe) (submittedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- irritable bowel syndrome, irritable bowel syndrome with constipation, probiotics, fermented milk, yogurt, health-related quality of life, bloating, stool frequency
- MeSH terms
- Adolescent, Adult, Aged, Bifidobacterium, Double-Blind Method, Female, Humans, Male, Middle Aged
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-11.
Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-11.
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