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 symptom
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 AdvantageTM 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.
Conclusions: 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
Author: Douglas KalmanHoward SchwartzPatricia AlvarezSamantha FeldmanJohn PezzulloDiane Krieger
Credits/Source: BMC Gastroenterology 2009, 9:85
Published on: 2009-11-18
Copyright by the authors listed above - made available via BioMedCentral (Open Access). Please
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