Original Contribution | Published:

Functional GI Disorders

Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating

The American Journal of Gastroenterology volume 112, pages 145151 (2017) | Download Citation

Abstract

OBJECTIVES:

Bifidobacterium infantis 35624 is a probiotic that is used often in patients with irritable bowel syndrome (IBS). Non-patients with bowel symptoms may differ from patients with IBS in the impact of their bowel symptoms on illness severity, healthcare and treatment seeking behavior. The aim of this study is to assess the efficacy of B. infantis 35624 (109 c.f.u. per day) for the relief of abdominal discomfort and bloating in a non-patient population.

METHODS:

A double-blind, randomized, placebo-controlled, parallel study with a 2-week placebo run-in phase followed by a 4-week intervention phase was conducted at ten clinical centers (USA). Subjects were recruited from the general population by advertisement. The study randomized 302 subjects who experienced abdominal discomfort and bloating ≥2-times per week for at least three months but have not seen a physician or received prescribed medication for their symptoms in the past 12 months. Subjects were assessed for pre- to post-intervention changes in symptom severity (on a 6-point Likert scale; 0=none, 5=very severe) and frequency (symptoms-free days).

RESULTS:

A total of 275 subjects (mean age 42 years, 79% female, 74% Caucasian) provided evaluable data. Overall mean severity scores at baseline were 2.4 for abdominal discomfort and 2.5 for bloating with no significant differences between the placebo and probiotic groups. Both groups showed significant (P<0.05) improvement in abdominal discomfort and bloating scores over the 4-week intervention period. Mean severity symptom scores at the end of intervention showed no significant differences between the probiotic and the placebo groups in either abdominal discomfort or bloating (P>0.3). The frequency of abdominal bloating-free days was greater in the B. infantis 35624 group compared to the placebo group (P<0.05). Both regimens were well tolerated.

CONCLUSIONS:

Unlike previous clinical studies in patients with IBS, B. infantis 35624 did not show a significant improvement in the mean severity of symptoms of abdominal discomfort and bloating in a non-patient population. This may be explained by the high placebo effect and the lower impact of functional bowel symptoms in the non-patient population.

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References

  1. 1.

    , , et al. Functional bowel disorders. Gastroenterology 2006;130:1480–1491.

  2. 2.

    , , . The epidemiology of irritable bowel syndrome in North America: a systematic review. Am J Gastroenterol 2002;97:1910–1915.

  3. 3.

    , , et al. Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States. Gastroenterology 2015;149:1731–41 e3.

  4. 4.

    , , . Postinfectious irritable bowel syndrome—a meta-analysis. Am J Gastroenterol 2006;101:1894–1899.

  5. 5.

    , , et al. Postinfectious irritable bowel syndrome: follow-up of a patient cohort of confirmed cases of bacterial infection with Salmonella or Campylobacter. Neurogastroenterol Motil 2011;23:e479–e488.

  6. 6.

    , , et al. Antibiotics increase functional abdominal symptoms. Am J Gastroenterol 2002;97:104–108.

  7. 7.

    , , et al. Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut 2013;62:159–176.

  8. 8.

    , . The intestinal microbiota and irritable bowel syndrome. J Clin Gastroenterol 2015;49 (Suppl 1): S56–S59.

  9. 9.

    , . Bacteria, Inflammation, and Immune Activation in the Pathogenesis of Irritable Bowel Syndrome. Am J Physiol Gastrointest Liver Physiol. 2013;305:G529–G541.

  10. 10.

    Food and Agriculture Organization of the United Nations, World Health Organization. Report of a Joint FAO/WHO Expert Consultation on Health and Nutritional Properties of Probiotics in Food Including Powder Milk With Live Lactic Acid Bacteria. Geneva, Switzerland: WHO. 2001.

  11. 11.

    , , et al. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology 2005;128:541–551.

  12. 12.

    , , et al. Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 2006;101:1581–1590.

  13. 13.

    , , et al. The prevalence, characteristics and impact of bloating symptoms in patients with irritable bowel syndrome. Clin Gastroenterol Hepatol 2009;7:68–72.

  14. 14.

    , , et al. Recommendations for probiotic use-2015 update: proceedings and consensus opinion. J Clin Gastroenterol 2015;49 (Suppl 1): S69–S73.

  15. 15.

    World Gastroenterology Organization Practice Guideline: probiotics and prebiotics. October 2011. Available at .

  16. 16.

    International Scientific Association for Probiotics and Prebiotics. Probiotics: a consumer guide for making smart choices, Available at .

  17. 17.

    , . Probiotics and prebiotics in dietetics practice. J Am Diet Assoc 2008;108:510–521.

  18. 18.

    American Gastroenterological Association Probiotics. What they are and what they can do for you. Available at .

  19. 19.

    National Center for Complementary and Alternative Medicine (NCCAM). National Institutes of Health, Oral probiotics: an introduction. Available at Updated on December 2012.

  20. 20.

    Food and Agriculture Organization of the United Nations and World Health Organization Guidelines for the evaluation of probiotics in food, 30 April and 1 May 2002. Available at .

  21. 21.

    , , et al. Characterization and comparison of patients versus non-patients with functional bowel symptoms in the general population. Gastroenterology 2010;138:S–384.

  22. 22.

    , . Meta-analysis: factors affecting placebo response rate in the irritable bowel syndrome. Alimen Pharm Ther 2010;32:144–158.

  23. 23.

    , , et al. Efficacy of prebiotics, probiotics, and synbiotics in irritable bowel syndrome and chronic idiopathic constipation: systematic review and meta-analysisAm J Gastroenterol 2014;109:1547–1561.

  24. 24.

    , , et al. Effect of antidepressants and psychological therapies,including hypnotherapy, in irritable bowel syndrome: systematic review and meta-analysis. Am J Gastroenterol 2014;109:1350–1365.

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Acknowledgements

This study was sponsored by P&G. ClinicalTrials.gov number NCT01099696.

Author information

Affiliations

  1. Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA

    • Tamar Ringel-Kulka
  2. The Procter & Gamble Company, Mason, Ohio, USA

    • Johnson McRorie
  3. School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA

    • Yehuda Ringel
  4. Department of Gastroenterology, Rabin Medical Center, Beilinson Hospital, Petach Tikva, Israel

    • Yehuda Ringel

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Competing interests

Guarantor of the article: Johnson McRorie, PhD.

Specific author contributions: Planning: Y.R. and J.M.; and/or conducting the study: Y.R. and T.R.K.; collecting: Y.R., T.R.K.; and/or interpreting data: Y.R., T.R.K., and J.M.; and/or drafting the manuscript: Y.R., T.R.K., and J.M.. Y.R. has approved the final draft submitted. T.R.K. has approved the final draft submitted. J.M. has approved the final draft submitted.

Financial support: This multi-site study was sponsored by P&G. The sponsor was responsible for the study design, protocol, data collection and analysis. Study sites were responsible for conduction of the study and assuring data collection according to protocol. The co-authors were responsible for interpretation of the data and writing of the report.

Potential competing interests: Dr R.-K. has received research funding from P&G. J.M. is a full-time employee of P&G, which markets probiotics. Y.R. and T.R.K. received research funding and Y.R. received consultation honorarium from P&G.

Corresponding author

Correspondence to Yehuda Ringel.

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DOI

https://doi.org/10.1038/ajg.2016.511