Email updates

Keep up to date with the latest news and content from BMC Gastroenterology and BioMed Central.

Open Access Highly Accessed Research article

A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms

Douglas S Kalman1*, Howard I Schwartz1, Patricia Alvarez2, Samantha Feldman1, John C Pezzullo1 and Diane R Krieger1

Author Affiliations

1 Miami Research Associates, 6141 Sunset Drive, Suite 301, South Miami, Florida 33143 USA

2 Latin American Research, Av. Maximo Gomez #60, Suite 201, Plaza Paseo Del Teatro, Santo Domingo, Dominican Republic

For all author emails, please log on.

BMC Gastroenterology 2009, 9:85  doi:10.1186/1471-230X-9-85

Published: 18 November 2009

Abstract

Background

This randomized double blind placebo controlled dual site clinical trial compared a probiotic dietary supplement to placebo regarding effects on gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms (abdominal pain, distention, flatulence) but no gastrointestinal (GI) diagnoses to explain the symptoms.

Methods

Sixty-one adults were enrolled (age 36.5 ± 12.6 years; height 165.1 ± 9.2 cm; weight 75.4 ± 17.3 kg) and randomized to either Digestive Advantage™ Gas Defense Formula - (GanedenBC30 Bacillus coagulans GBI-30, 6086): n = 30; or Placebo: n = 31. Study subjects were evaluated every two weeks over a four-week period using validated questionnaires and standard biochemical safety testing. Outcome criteria of interest included change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) abdominal pain, abdominal distention, flatus, and the Severity of Dyspepsia Assessment (SODA) bloating and gas subscores over four weeks of product use.

Results

Measured against the placebo, subjects in the probiotic group achieved significant improvements in GSRS abdominal pain subscore (p = 0.046) and the GSRS total score (p = 0.048), with a strong trend for improvement on the GSRS abdominal distension subscore (p = 0.061). A strong placebo effect was evident which could explain the lack of statistical significant differences between the groups for many of the efficacy variables.

Conclusion

In conclusion, the Bacillus coagulans-based product was effective in improving the quality of life and reducing gastrointestinal symptoms in adults with post prandial intestinal gas-related symptoms and no GI diagnoses.

Trial Registration

ClinicalTrials.gov Identifier: NCT00881322