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

Abstract

BackgroundThis 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.MethodsSixty-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.ResultsMeasured 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.ConclusionIn 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 RegistrationClinicalTrials.gov Identifier: NCT00881322

Systematic review: probiotics in the management of lower gastrointestinal symptoms – an updated evidence‐based international consensus

“…The majority of the 70 studies (Table S1) focused on IBS (based on Rome I, II or III criteria or physician diagnosis; 34 studies), antibiotic‐associated diarrhoea (13 studies) or diarrhoea‐associated Helicobacter pylori eradication therapy (7 studies). Other conditions were investigated in 16 studies.…”

“…Six studies investigated the effect of 6 different probiotics on distension/bloating in indications other than IBS. One of these studies (included in the original consensus) evaluated symptoms related to post‐prandial intestinal gas as a primary endpoint in healthy individuals and reported no significant differences between the probiotic and placebo groups . The remaining 5 studies (examining 5 different probiotics) evaluated distension/bloating as a secondary endpoint.…”

“…Seven studies examined the effect of 7 different probiotics on flatus in indications other than IBS. Four of these studies reported no significant effects on flatus (primary endpoint for 1 probiotic and secondary endpoint for 3 other probiotics). Three studies reported a significant benefit of 3 different probiotic treatments on flatus (secondary endpoint) in women with mild digestive symptoms, patients with functional GI symptoms and individuals with lactose intolerance undergoing a lactose breath test .…”

The Effects of Synbiotic Supplementation on Constipation and Reducing Flatulence in Stroke Patients Admitted to the ICU

“…These results of this study showed that probiotic supplementation in stroke patients admitted to the ICU increased frequency of bowel movements and constipation, and could possibly improve complications of constipation in these patients [20]. In research by Kalman et of Bacilus Coagulate on functional intestinal gas symptoms" carried out it was found that consumption of products containing Bacillus Coagulan reduce gastrointestinal symptoms associated gases of meals, especially abdominal pain and distention after a meal linked (p=0.046) [21]. Overall the results of this study showed that consumption of symbiotic supplement in stroke patients admitted to the ICU increased frequency of bowel movements and constipation and could possibly improve discomfort caused by abdominal bloating in these patients.…”

Draft Genome Sequence of Bacillus coagulans GBI-30, 6086, a Widely Used Spore-Forming Probiotic Strain

“…This strain is characterized by certified beneficial effects in gastrointestinal disorders, such as irritable bowel syndrome, intestinal gas, and colitis (2, 3, 4, 5); in rheumatoid arthritis (6); and in common viral infections of the respiratory tract (7). As a sporeformer, B. coagulans GBI-30, 6086 can be incorporated into foods, where it can survive the mild heat-treatments used for sterilization andwithstand the harsh conditions of the gastrointestinal tract, i.e., the low pH of the gastric barrier (8).…”