Skip to main content

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.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bacillus coagulans GBI-30, 6086Improved Quality of LifeBeneficial
Small
Bacillus coagulans GBI-30, 6086Reduced Abdominal DistensionBeneficial
Small
Bacillus coagulans GBI-30, 6086Reduced Abdominal PainBeneficial
Small
Bacillus coagulans GBI-30, 6086Reduced Gastrointestinal SymptomsBeneficial
Moderate
Bacillus coagulans ProDuraReduced Abdominal DistensionBeneficial
Small
Bacillus coagulans ProDuraReduced Abdominal PainBeneficial
Small
Bacillus coagulans ProDuraReduced Gastrointestinal SymptomsBeneficial
Moderate
Bacillus coagulans SNZ-1969Reduced Abdominal PainBeneficial
Small
Bacillus coagulans SNZ-1969Reduced Gastrointestinal SymptomsBeneficial
Moderate

Pillser helps you make informed health decisions by providing comprehensive, unbiased information about supplements. This includes detailed research on supplement ingredients, their benefits, potential risks, and their overall efficacy. You can contribute by sharing your feedback and suggestions.

Send us an email at support@pillser.com.