Cited by 95Probiotics and Fermented FoodsGastrointestinal motility and disordersGut microbiota and health

Fermented milk containing Bifidobacterium lactis DN-173 010 improves gastrointestinal well-being and digestive symptoms in women reporting minor digestive symptoms: a randomised, double-blind, parallel, controlled study

Open access
Guyonnet, Denis, Schlumberger, Armelle, Mhamdi, Leila, Jakob, Stefan, Chassany, Olivier·2009·British Journal of Nutrition

Abstract

The ability of probiotics to improve bowel habits or transit time has been shown in healthy populations. Additional data are required to support the use of specific probiotics to improve gastrointestinal (GI) well-being. The present study was designed to investigate the effect of consuming fermented milk (FM) on GI well-being, digestive symptoms and health-related quality of life (HRQoL) amongst women without diagnosed GI disorders. In this double-blind, controlled, parallel-design study, subjects were randomised to ingest daily either 2 × 125 g FM containing Bifidobacterium lactis DN-173 010 and yoghurt strains or a control non-fermented dairy product for 4 weeks followed by a 4-week wash-out period. GI well-being and digestive symptoms were assessed weekly. HRQoL was measured every 4 weeks. Data were analysed using analysis of covariance and logistic regression, correcting for baseline values on the full analysis set population of 197 women (aged 18–60 years). The percentage of women reporting an improvement in their GI well-being was significantly (P < 0·01) higher in the FM group v. the control group (OR 1·69; 95 % CI 1·17, 2·45). A significantly (P < 0·05) more pronounced decrease in the composite score of digestive symptoms was observed in the FM group when comparing with the control group (least squares mean − 0·57; 95 % CI − 1·12, − 0·02). Among HRQoL dimensions, the digestive comfort score was significantly (P < 0·05) improved in the FM group compared with the control group. The present study showed that the daily consumption of a specific FM is able to improve GI well-being and digestive symptoms in adult women without GI disorders.

Integrity signals

Registry

Crossref · 10.1017/s0007114509990882

Cites

41 of 41 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 75 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    The probiotic product decreased the composite score of the frequency of gastrointestinal symptoms.

    “Furthermore, this probiotic product decreased the composite score of the frequency of GI symptoms.”
    Quote in the paperSubstantial claim
  • Findingown data

    Stool consistency significantly decreased in the fermented milk group compared with the control group (P=0.02).

    “A significant (P¼0•02) decrease of the stool consistency was observed in the FM group v. the control group.”
    Quote in the paperSubstantial claim
  • Findingown data

    The percentage of women reporting improved GI well-being was significantly higher in the FM group than control (OR 1.7; 95% CI 1.17, 2.45; P=0.006).

    “The percentage of women reporting an improvement in their GI well-being was significantly (P¼0•006) higher in the FM group v. the control group (OR 1•7; 95 % CI 1•17, 2•45).”
    Quote in the paperSubstantial claim
  • Findingown data

    Borborygmi frequency decreased significantly more in FM than control over 4 weeks (LS mean -0.22; 95% CI -0.40, -0.04; P=0.016).

    “Changes in borborygmi frequency showed a significantly (P¼0•016) higher decrease in the FM group compared with the control group over the 4-week period (least squares mean 2 0•22; 95 % CI 2 0•40, 2 0•04).”
    Quote in the paperSubstantial claim
  • Findingown data

    The digestive comfort dimension score significantly increased after 4 weeks of product consumption in the fermented milk group compared with the control group (P=0.027).

    “The digestive comfort dimension score, the primary HRQoL endpoint, significantly increased (P¼0•027) after 4 weeks of product consumption in the FM group as compared with the control group.”
    Quote in the paperSubstantial claim
  • May combine two claims. 26
  • Classified as probably not a substantial claim. 16
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    Findingown data

    In this trial, GI well-being and digestive symptoms improved while bowel frequency did not change.

    “In the present study, GI well-being and symptoms improved without change of bowel frequency.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingreasoning

    In this study, the improvement in HRQoL was less pronounced and less clear than the improvement in GI well-being and symptoms.

    “We acknowledge that despite the significant and evident effect on GI well-being and symptoms, the improvement of HRQoL remains less pronounced and is not so clear-cut.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    The observed between-group difference in digestive comfort score was 3.56, which is inferior to the minimal important difference of 10.9.

    “The observed difference between group (3•56) is inferior to the MID (10•9).”
    Quote in the paperSubstantial claim
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    Findingown data

    After stopping the product, the effect dropped sharply in the first week and then declined slowly over the next three weeks.

    “It was noticeable that a dramatic loss of the effect of the product was observed within the first week of ceasing to use the product whereas a slow but gradual loss of the effect was observed during the following 3 weeks of the follow-up period.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Using a priori MID definitions, there was a trend favoring the tested product for responder rate, while the statistically significant score change was below clinical relevance threshold.

    “Using this very rigorous method of assessment, a trend in favour of the tested product was obtained for the rate of responders whereas the statistically significant difference in the score changes was below the threshold of clinical relevance.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [24]

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  • May combine two claims.

    Findingown data

    The fifteen-point GI well-being score was significantly higher in FM than control at week 1 (P=0.001) and week 3 (P=0.047).

    “The weekly analysis of the fifteen-point scale score showed a significant higher score at weeks 1 (P¼0•001) and 3 (P¼0•047) in the FM group compared with the control group.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Stool frequency and stool consistency did not differ between FM and control groups.

    “Stool frequency as well as score of stool consistency did not differ between the FM product and control groups (data not shown).”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    At the end of wash-out, the responder percentage decreased strongly and did not differ between groups (8.0 vs 11.3%; OR 0.68; 95% CI 0.26, 1.77).

    “At the end of the wash-out period, the percentage of responders strongly decreased without difference between the groups (8•0 v. 11•3 % for the FM and control groups, respectively; OR 0•68; 95 % CI 0•26, 1•77).”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductown data

    The two products lacked flavour and were alike in appearance, texture, and taste.

    “Both the test and control products were without flavour and had a similar appearance, texture and taste.”
    Quote in the paperSubstantial claim
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    Interpretationcitation

    These data support that the specific fermented milk improves some gastrointestinal functions in both healthy and irritable bowel syndrome populations.

    “These data support the ability of this specific FM to improve some GI functions in both healthy and IBS populations.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Premisecitation

    Only one study has investigated the impact of probiotics on a specific digestive symptom, flatulence, and found a positive effect.

    “Unfortunately, only one study (4) has investigated the impact on a specific digestive symptom (i.e.flatulence), showing a positive effect on this parameter; therefore, the real end-benefits of such functional changes for the consumers are open to question.”
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  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductcitation

    The gastrointestinal well-being scale was adapted from the Guyatt scale and used in irritable bowel syndrome studies.

    “This scale was adapted from the scale developed by Guyatt et al. (18) and used in IBS studies (19) .”
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    Study design and conductcitation

    Bowel movements and stool consistency were assessed using the Bristol stool form scale.

    “Bowel movements were reported daily throughout the study as well as stool consistency for each stool passed according to the Bristol stool form scale (20) .”
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    Premisenone given

    Only a few studies have examined the effects of probiotics on gastrointestinal well-being in a general population.

    “Only a few studies have been focused on the effects of probiotics on gastrointestinal (GI) well-being in a general population.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    The study was single-centre, randomised, double-blind, controlled, and parallel-group.

    “The study was a single-centre, randomised, double blind, controlled, parallel-group study assessing the effect of daily consumption of a FM containing B. lactis DN-173 010 (FM group) v. a non-fermented dairy product (control group).”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Study design and conductcitation

    The responder definition was based on recommendations for global assessment of symptom relief in irritable bowel syndrome trials.

    “The definition of a responder was based on the recommendations for global assessment of symptom relief in IBS trials (19) , which is the only available recommendation for such kinds of assessment.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [19] source

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  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Probiotics have been shown to improve bowel habits or transit time in healthy populations.

    “The ability of probiotics to improve bowel habits or transit time has been shown in healthy populations.”
    Quote in the paperNot a substantial claim0 of 8 sources checked
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  • May combine two claims.

    Premisecitation

    Probiotics increase stool frequency, stool volume or weight, and stool consistency.

    “Improvement of stool frequency and/or volume or weight, and stool consistency has been shown (4 -8) .”
    Quote in the paperSubstantial claim0 of 5 sources checked
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  • May combine two claims.

    Premisecitation

    Most studies of probiotics on gastrointestinal well-being in the general population investigated bowel habits and used small samples of thirty to eighty subjects.

    “Most of these studies have investigated the effect of probiotics on bowel habits and were conducted in small sample sizes (from thirty to eighty subjects).”
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  • May combine two claims.

    Premisecitation

    The fermented dairy product studied can shorten transit time in healthy people and in IBS patients.

    “The fermented dairy product used in the present study is also able to decrease transit time in both healthy (15 -17) and IBS populations (13) .”
    Quote in the paperNot a substantial claim0 of 4 sources checked
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  • May combine two claims.

    Interpretationreasoning

    Taken with prior transit and IBS data, the specific probiotic food may be a promising nutritional and safe option for managing GI symptoms.

    “These data, taken together with previous data obtained on GI transit and in IBS, suggest that this specific probiotic food may represent a promising nutritional and safe solution for the management of GI symptoms.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The study product is safe for the population studied.
    • Rests on an assumption: The observed benefits are attributable to the B. lactis DN-173 010 strain rather than to other components of the fermented milk.
  • May combine two claims.

    Interpretationcitation

    The number needed to treat in the present study (6.25) is similar to that observed (5.7) in a previous irritable bowel syndrome study and within the same range as values (4 and 7.3) in recent reviews of irritable bowel syndrome probiotics trials.

    “The NNT of the present study (6•25) is similar to the one observed (5•7) in a previous IBS study (14) and within the same range as NNT calculated (4 and 7•3) in recent reviews of IBS probiotics trials (28,31) .”
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  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Symptoms arising from the gut belong to normal digestion and occur in the general population.

    “Gut-derived symptoms are part of the normal physiological digestive process and are experienced by the general population (29,30) .”
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    Study design and conductcitation

    The full analysis set definition agrees with International Conference of Harmonisation guidances.

    “This definition of the FAS population is in agreement with the International Conference of Harmonisation guidances (25) .”
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    Premisecitation

    Clinical benefit between studies can be compared using the number needed to treat, which is based on the difference in responders between groups.

    “The comparison of the clinical benefit between these studies can be done using the number needed to treat (NNT) (32,33) , which is based on the difference of responders between groups.”
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  • May combine two claims.

    Premisecitation

    In healthy volunteers, faecal B. lactis levels after consuming the product followed similar kinetics: maximum after 4 weeks, decrease within a week after stopping, and undetectable after 4-5 weeks.

    “Interestingly, it was shown that the level of B. lactis in the faeces of healthy volunteers consuming the study product followed a similar kinetics, with a maximal level reached after 4 weeks of consumption followed by a decrease within a week after discontinuation of use of the product and a non-detectable level after 4-5 weeks (38) .”
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  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Efficacy analyses were performed on the full analysis set of all randomised subjects with any efficacy data under product consumption.

    “All the analyses of efficacy were performed on the full analysis set (FAS) population which corresponds to all randomised subjects having any efficacy data available under product consumption.”
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    Premisecitation

    Research has focused on assessing potential negative gut sensations associated with consumption of fibres and probiotics.

    “Indeed, research has focused on the assessment of potential negative sensations from the gut associated with the consumption of both fibres (26) and probiotics (27) .”
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  • May combine two claims.

    Interpretationown data

    Daily consumption of the specific fermented milk improves gastrointestinal well-being and digestive symptoms in adult women without gastrointestinal disorders.

    “The present study showed that the daily consumption of a specific FM is able to improve GI well-being and digestive symptoms in adult women without GI disorders.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The sample of women recruited at one German centre is representative of adult women without gastrointestinal disorders.
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Compliance during the study was 99.2% in the control group and 99.3% in the fermented milk group.

    “The compliance during the study was 99•2 and 99•3 % for the control and FM groups, respectively.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Premisecitation

    Prior work has shown probiotic effects on bowel function in healthy people, but no study examined digestive comfort or gastrointestinal symptoms.

    “Several studies have reported effects of probiotics on bowel function in healthy populations (4 -7,15) but none of them has assessed the effect on digestive comfort or GI symptoms.”
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  • May combine two claims.

    Interpretationown data

    A specific probiotic food shown to improve digestive symptoms in irritable bowel syndrome also improves gastrointestinal well-being and digestive symptoms in individuals without gastrointestinal diseases.

    “The present study shows that a specific probiotic food that has been shown to improve digestive symptoms in IBS (13,14) is also able to improve GI well-being and digestive symptoms in individuals who do not suffer from GI diseases.”
    Quote in the paperSubstantial claim0 of 2 sources checked
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    • Rests on an assumption: The sample of women recruited at one German centre is representative of adult women without gastrointestinal disorders.
  • Classified as probably not a substantial claim.

    Study design and conductown data

    The sample size was calculated to need at least eighty-four subjects per group to have 80% power to detect a 20% greater improvement rate in the test-product group at 4 weeks.

    “The trial sample size required to give a power of 80 % for detecting a significant difference between the control and test products of 20 % more subjects improved in the test-product group at 4 weeks was calculated to be at least eighty-four subjects per group.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Five subjects left the 4-week double-blind phase before completion and had no follow-up data, leaving a full analysis set of 197.

    “Of the subjects, five did not complete the entire 4-week double-blind period and were lost to follow-up (no data available under product consumption), giving an FAS population of 197.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    The study protocol was approved by the Ethics Committee Bayerische Landesaerztekammer and all volunteers gave written informed consent.

    “The study protocol was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee Bayerische Landesaerztekammer (Munich, Germany).All volunteers gave written informed consent before inclusion in the study.”
    Quote in the paperNot a substantial claim
35 of 35
  • The paper relies on this without support.

    The sample of women recruited at one German centre is representative of adult women without gastrointestinal disorders.

    “They were all women, aged 18 -60 years, with normal weight or overweight (BMI 18 -30 kg/m 2 ), without a diagnosis of any digestive disease including functional bowel disorders such as IBS.”
  • The paper relies on this without support.

    The study product is safe for the population studied.

    “suggest that this specific probiotic food may represent a promising nutritional and safe solution for the management of GI symptoms.”
  • The paper relies on this without support.

    The observed benefits are attributable to the B. lactis DN-173 010 strain rather than to other components of the fermented milk.

    “In conclusion, the present study demonstrated that this probiotic food containing the specific B. lactis DN-173 010 strain is able to improve GI well-being as well as GI symptoms in a population of women reporting minor digestive disorders.”
3 of 3

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Research works printed but not linked: 1

  1. 1998, ICH Topic E 9. Statistical Principles for Clinical Trials

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Authors
Guyonnet, D., Schlumberger, A., Mhamdi, L., Jakob, S., & Chassany, O.
Affiliations
  • Danone (France) (FR)
  • Assistance Publique – Hôpitaux de Paris (FR)
Corresponding author
Guyonnet, Denis
Venue
British Journal of Nutrition
Published
2009-07-22
Volume
102
Issue
11
Pages
1654-1662
ISSN
  • 0007-1145 (ISSN-L)
  • 1475-2662
OpenAlex
W2076786278
Cited by
95
References
43
Citations by year
2026: 2 · 2025: 5 · 2024: 2 · 2023: 3 · 2022: 3 · 2021: 9 · 2020: 4 · 2019: 7 · 2018: 6 · 2017: 8 · 2016: 6 · 2015: 6 · 2014: 9 · 2013: 9 · 2012: 2
FWCI
8.45
Type
journal article
Language
en
Open access
Locations
  • British Journal Of Nutrition (publishedVersion)
  • PubMed (publishedVersion)
Funders
Danone
Topics
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
Keywords
fermented milk, probiotics, gastrointestinal symptoms, health-related quality of life, women, yogurt, bowel habits
MeSH terms
Adolescent, Adult, Bifidobacterium, Defecation, Digestion, Double-Blind Method, Female, Fermentation, Flatulence, Gastrointestinal Transit, Humans, Middle Aged, Quality of Life, Yogurt, Abdominal Pain, Probiotics, Gastrointestinal Tract, Young Adult

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