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Cited by 156Gastrointestinal motility and disordersProbiotics and Fermented FoodsGut microbiota and health

The DOI matches its Crossref record; 70 of the 70 references it cites were found in a registry or an index; none of the 20 sources its claims cite is checked for support yet.

Clinical trial: a multistrain probiotic preparation significantly reduces symptoms of irritable bowel syndrome in a double-blind placebo-controlled study

Open access
WILLIAMS, E. A., STIMPSON, J., WANG, D., PLUMMER, S., GARAIOVA, I., BARKER, M. E., CORFE, B. M.·2009·Alimentary Pharmacology & Therapeutics
DOI 10.1111/j.1365-2036.2008.03848.x
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Abstract

Summary: Background The efficacy of probiotics in alleviating the symptoms of irritable bowel syndrome (IBS) appears to be both strain‐ and dose‐related. Aim To investigate the effect of LAB4, a multistrain probiotic preparation on symptoms of IBS. This probiotic preparation has not previously been assessed in IBS. Methods Fifty‐two participants with IBS, as defined by the Rome II criteria, participated in this double blind, randomized, placebo‐controlled study. Participants were randomized to receive either a probiotic preparation comprising two strains of Lactobacillus acidophilus CUL60 (NCIMB 30157) and CUL21 (NCIMB 30156), Bifidobacterium lactis CUL34 (NCIMB 30172) and Bifidobacterium bifidum CUL20 (NCIMB 30153) at a total of 2.5 × 10 10 cfu/capsule or a placebo for 8 weeks. Participants reported their IBS symptoms using a questionnaire fortnightly during the intervention and at 2 weeks post‐intervention. Results A significantly greater improvement in the Symptom Severity Score of IBS and in scores for quality of life, days with pain and satisfaction with bowel habit was observed over the 8‐week intervention period in the volunteers receiving the probiotic preparation than in the placebo group. Conclusion LAB4 multistrain probiotic supplement may benefit subjects with IBS.

Overview

Integrity signals

Registry

Crossref · 10.1111/j.1365-2036.2008.03848.x

Cites

70 of 70 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Verification

Claims the paper makes

0 of 20 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    In participants with IBS, the LAB4 probiotic produced significantly greater improvement in quality of life than placebo at the end of the 8-week intervention (week 8).

    “A significantly greater improvement in the Symptom Severity Score of IBS and in scores for quality of life, days with pain and satisfaction with bowel habit was observed over the 8-week intervention period in the volunteers receiving the probiotic preparation than in the placebo group.”
    • Also stated in: § RESULTS · plain
      “Significant improvements in quality of life (Figure 3a) were recorded for those receiving the probiotic at the end of the intervention period (P = 0.0068; difference between groups: )13.58; 95% CI: )23.38 to )3.78 at week 8)”
    Quote in the paperSubstantial claim
  • Findingown data

    In participants with IBS, the LAB4 multistrain probiotic produced a significantly greater improvement in IBS Symptom Severity Score than placebo over the 8-week intervention period.

    “A significantly greater improvement in the Symptom Severity Score of IBS and in scores for quality of life, days with pain and satisfaction with bowel habit was observed over the 8-week intervention period in the volunteers receiving the probiotic preparation than in the placebo group.”
    • Also stated in: § DISCUSSION · plain
      “Significant differences in the Symptom Severity Score were recorded between the probiotic and placebo groups correlating with improved quality of life and bowel habit together with fewer numbers of days with pain for the probiotic group.”
    Quote in the paperSubstantial claim
  • Findingown data

    Greater improvements were recorded for all symptoms for the probiotic group than for the placebo group throughout the study.

    “Figure 3 shows that greater improvements were recorded for all symptoms for the probiotic group than for the placebo group throughout the study.”
    Quote in the paperSubstantial claim
  • Findingown data

    The severity of abdominal pain reduced significantly in both groups from week 4 onwards.

    “The severity of abdominal pain reduced significantly in both groups from week 4 onwards (probiotic: P < 0.0001, LS mean )19.05, 95% CI: )27.41 to )10.70; placebo: P = 0.0185, LS mean )10.88, 95% CI: )19.93 to )1.84).”
    Quote in the paperNot a substantial claim
  • Findingown data

    No differences in abdominal pain or bloating were discernible between the probiotic and placebo groups.

    “No differences in abdominal pain or bloating were discernible between the two groups.”
    Quote in the paperNot a substantial claim
  • The quote only partly states this claim. 1
  • It may state two separate claims as one. 14
  • Probably not a substantial claim. 14

  • The quote only partly states this claim.

    Findingown data

    The overall P-value for the ANOVA analysis evaluating all time points for Symptom Severity Score was 0.0008.

    “The overall P-value for the ANOVA analysis evaluating all time points was 0.0008.”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Findingnone given

    The probiotic was well tolerated and free from significant adverse effects.

    “The use of the probiotic was well tolerated and free from significant adverse effects.”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Findingown data

    In both groups, significant improvements from baseline were reported in quality of life and satisfaction with bowel habit throughout the study.

    “More detailed analysis of these symptoms showed that significant improvements from the baseline were reported in quality of life and satisfaction with bowel habit in both groups throughout the study.”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Findingown data

    The overall placebo effect for the Symptom Severity Score in this study was 33%, ranging from 23% to 45% for individual symptoms.

    “The overall placebo effect for the Symptom Severity Score in this study was 33% ranging from 23% to 45% for the individual symptoms.”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Findingown data

    In the probiotic group, abdominal pain/bloating symptoms did not show significant improvement from baseline until week 4; in the placebo group, significant improvements in these symptoms were only recorded at weeks 6 and 8.

    “Abdominal pain ⁄ bloating symptoms did not show significant improvements from the baseline in the probiotic group until week 4 (P = 0.0002; LS mean )16.10; 95% CI: )24.64 to )7.56) of intervention and that in the placebo group, significant improvements in these symptoms were only recorded at week 6 (P = 0.0218; LS mean )11.04; 95% CI: )20.46 to )1.62) and week 8 (P = 0.0028; LS mean )14.74; 95% CI”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Study design and conductown data

    The study was double-blind and placebo-controlled.

    “This was a double-blind placebo-controlled study to evaluate the efficacy of a multistrain probiotic preparation in the treatment of IBS.”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Study design and conductown data

    The two groups of subjects were similar in age, gender, type of bowel habit and symptoms at baseline.

    “The two groups of subjects were similar in terms of age, gender, type of bowel habit and symptoms.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.

    Study design and conductown data

    The sample size was calculated based on a 15% reduction in severity of symptoms; 50 subjects were needed to detect a difference with 80% power at the 5% significance level; the sample size was increased to 56 to allow for just over 10% drop out.

    “The sample size was calculated based on a 15% reduction in severity of symptoms.It was calculated that 50 subjects (25 in each group of the study) were needed to detect a difference between the two groups with a power of 80% at the 5% level of statistical significance.The sample size was increased to 56 subjects to allow for just over 10% drop out rate.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Study design and conductown data

    Subjects receiving the probiotic had a higher IBS severity score at baseline than subjects receiving placebo (mean 283 vs 252).

    “Subjects receiving the probiotic preparation had a higher IBS severity score at baseline than the subjects receiving placebo (mean Æ s.d.283 Æ 61 vs. 252 Æ 60 respectively).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Study design and conductnone given

    Compliance was assessed by counting the number of capsules remaining at the end of the intervention and checked against self-reported capsule diaries.

    “Compliance was assessed by counting the number of capsules remaining at the end of the intervention and checked against self-reported capsule diaries.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.

    Study design and conductown data

    Of the fifty-six volunteers recruited, four subjects in the placebo arm withdrew; fifty-two subjects participated in the intervention (28 treatment, 24 control); four subjects failed to return all questionnaires.

    “Of the fifty-six volunteers recruited, four subjects in the placebo arm withdrew from the study (one due to ill health, two for deviation from protocol and one for unknown reasons) (Figure 1).Fifty-two subjects participated in the intervention comprising 28 subjects in the treatment group and 24 subjects in the control group (Table 1).Four subjects (two in each treatment arm) failed to return all”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Interpretationcitation

    The overall placebo response rate observed in this study (33%) is comparable with that seen in many other IBS studies.

    “The overall placebo response rate observed in this study (33%) is comparable with that seen in many other IBS studies.Patel et al. 14 concluded that placebo effects in IBS clinical trials measuring global outcome were highly variable ranging from 16 to 71%, whereas Dorn et al. 15 found a placebo response rate of 42.6% in complementary and alternative medicine IBS trials.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [14] source
    • cites [15] source

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Study design and conductown data

    Randomization was stratified by age and gender.

    “Fifty-six subjects were recruited to the study and randomized (stratified by age and gender) to receive probiotic treatment (n = 28) and placebo treatment (n = 28).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Premisecitation

    Dorn et al. found a placebo response rate of 42.6% in complementary and alternative medicine IBS trials.

    “Dorn et al. 15 found a placebo response rate of 42.6% in complementary and alternative medicine IBS trials.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [15] source

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Premisecitation

    Whorwell et al. indicated that there may be a dose responsiveness to the administration of B. infantis.

    “the results of Whorwell et al. 24 indicated that there may be a dose responsiveness to the administration of B. infantis”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [24] source

  • Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.

    Premisecitation

    Several factors are thought to contribute to the placebo effect, including Pavlovian conditioning and the expectation of a positive outcome.

    “Several factors are thought to contribute towards the placebo effect including Pavlovian conditioning and the expectation of a positive outcome.16”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [16] source

  • It may state two separate claims as one.

    Interpretationreasoning

    In this trial, volunteers were informed of the possible benefits of a probiotic and may have anticipated improvement, which likely contributed to the placebo effect.

    “In this trial all, volunteers had been informed that the purpose of the study was to investigate the possible benefits of a probiotic preparation, although they knew that they may be receiving a placebo.Owing to the nature of the intervention the volunteers may have been anticipating an improvement in their IBS symptoms which is likely to have contributed towards the placebo effect.”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Premisecitation

    The consortium and dose used in this study had previously proved effective in prevention of Clostridium difficile in vivo and in modulation of the composition of the intestinal re-growth population following antibiotic therapy.

    “The consortium and dose used in this study had previously proved effective in both prevention of Clostridium difficile in vivo 8,9 and the modulation of the composition of the intestinal re-growth population following antibiotic therapy.10,11”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [8] source
    • cites [9]
    • cites [10] source

  • It may state two separate claims as one.

    Premisecitation

    Kassinen et al. showed that both the lactobacillus and bifidobacterial components of the microbiota of IBS sufferers were present in lower numbers than in controls, suggesting a value for intervention strategies comprising both organisms.

    “Kassinen et al. 8 have shown that both the lactobacillus and the bifidobacterial components of the microbiota of IBS sufferers were present in lower numbers than in the controls suggesting a value for intervention strategies comprising both organisms.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [8] source

  • Probably not a substantial claim.

    Premisecitation

    It has been proposed that IBS may result from a dysfunctional interaction between the indigenous flora and the intestinal mucosa leading to immune activation in the colonic mucosa.

    “It has been proposed that IBS may result from a dysfunctional interaction between the indigenous flora and the intestinal mucosa leading to immune activation in the colonic mucosa. 2”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [2] source

  • It may state two separate claims as one.

    Premisecitation

    Most randomized controlled trials of multistrain probiotics in IBS provided daily doses in the range of 5-9 × 10^9 cfu, and in most cases reductions in symptom severity score were observed; some but not all products significantly reduced abdominal pain symptoms.

    “Most of the products provided daily doses in the range of 5-9 • 10 9 cfu and, in most cases, reductions in symptom severity score were observed [17][18][19][20][21] and some, but not all, of the products significantly reduced abdominal pain symptoms.”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [17] source
    • cites [18] source
    • cites [19] source

  • Probably not a substantial claim.

    Study design and conductown data

    The probiotic and placebo preparations were prepared as identically packaged, cellulose capsules.

    “The probiotic and the placebo preparations were prepared as identically packaged, cellulose capsules by Cultech Ltd, Port Talbot, UK.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim. It may state two separate claims as one.

    Study design and conductnone given

    All volunteers reported a previous diagnosis of IBS by their general practitioner, but GP records were not checked.

    “All volunteers reported a previous diagnosis of IBS by their general practitioner (GP), but GP records were not checked.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Premisecitation

    Patel et al. concluded that placebo effects in IBS clinical trials measuring global outcome were highly variable, ranging from 16% to 71%.

    “Patel et al. 14 concluded that placebo effects in IBS clinical trials measuring global outcome were highly variable ranging from 16 to 71%”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [14] source

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Premisecitation

    Quigley and Flourie suggested a clear rationale for probiotic usage in IBS in response to a dysfunctional relationship between the indigenous microbiota and the host.

    “Quigley and Flourie 7 reviewed the use and efficacy of probiotics in IBS and suggested a clear rationale for probiotic usage in response to a dysfunctional relationship between the indigenous microbiota and the host.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [7] source
25 of 25

  • The authors state this as an assumption.

    Missing questionnaire data are missing at random in the ANOVA model analysis.

    “imputedbut are assumed to be missing at random in the ANOVA model analysis.”

  • The paper relies on this without support.

    The LAB4 probiotic preparation had not previously been assessed in IBS.

    “This probiotic preparation has not previously been assessed in IBS.”

  • The paper relies on this without support.

    The efficacy of probiotics in IBS is strain- and dose-related.

    “The efficacy of probiotics in alleviating the symptoms of irritable bowel syndrome (IBS) appears to be both strain-and dose-related.”
3 of 3

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Research works printed but not linked: 1

  1. FAO/WHO, 2001, Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria

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Metadata

Authors
WILLIAMS, E. A., STIMPSON, J., WANG, D., PLUMMER, S., GARAIOVA, I., BARKER, M. E., & CORFE, B. M.
Affiliations
  • University of Sheffield (GB)
  • London School of Hygiene & Tropical Medicine (GB)
  • Altran (United Kingdom) (GB)
Corresponding author
WILLIAMS, E. A.
ORCID
Venue
Alimentary Pharmacology & Therapeutics
Publisher
Wiley
Published
2008-12-16
Volume
29
Issue
1
Pages
97-103
ISSN
  • 0269-2813 (ISSN-L)
  • 1365-2036
DOI
10.1111/j.1365-2036.2008.03848.x
OpenAlex
W2147884617
Semantic Scholar
8e9a6fa5a64371a4607c3eca56493cd8daa9c5d9
Cited by
156
References
70
Citations by year
2026: 2 · 2025: 7 · 2024: 12 · 2023: 8 · 2022: 4 · 2021: 9 · 2020: 9 · 2019: 7 · 2018: 9 · 2017: 11 · 2016: 11 · 2015: 9 · 2014: 12 · 2013: 13 · 2012: 12
FWCI
6.91
Type
journal article
Language
en
Open access
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Alimentary Pharmacology & Therapeutics (publishedVersion)
  • PubMed (publishedVersion)
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, probiotics, Lactobacillus acidophilus, Bifidobacterium animalis subsp. lactis, Bifidobacterium bifidum, IBS symptom severity, quality of life, abdominal pain, bowel habits, Rome II criteria
MeSH terms
Adult, Analysis of Variance, Bifidobacterium, Defecation, Double-Blind Method, Female, Humans, Lactobacillus acidophilus, Male, Middle Aged, Placebos, Surveys and Questionnaires, Severity of Illness Index, Time Factors, Treatment Outcome, Probiotics, Irritable Bowel Syndrome

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