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A Randomized Double Blind Pilot Clinical Trial Evaluating a Probiotic for Post‐Prandial Gastric Distress and Quality of Life
Author(s) -
Kalman Douglas,
Feldman Samantha,
Schwartz Howard,
Krieger Diane
Publication year - 2009
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.23.1_supplement.lb460
Subject(s) - bloating , flatulence , medicine , placebo , abdominal pain , abdominal distension , randomized controlled trial , distress , quality of life (healthcare) , probiotic , placebo controlled study , nausea , gastroenterology , physical therapy , double blind , clinical psychology , alternative medicine , nursing , pathology , biology , bacteria , genetics
This randomized double blind placebo controlled dual site clinical trial compared a probiotic dietary supplement to placebo regarding effects on gastrointestinal symptoms in otherwise healthy adults who complained of post‐prandial intestinal gas‐related symptoms (positive for at least one of the following: abdominal pain/cramps, distended feeling/bloating, flatulence/gas). 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 Gas Defense(tm) ‐ (GanedenBC 30 Bacillus coaglans 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. Measured against placebo, subjects in the probiotic group achieved significant improvements in GSRS Abdominal Pain (p = 0.042) with strong trends for improvement also on the GSRS Abdominal Distension (p = 0.052) and the GSRS total score (p = 0.055). A strong placebo effect was evident which could explain the lack of statistically significant differences between the groups for many of the efficacy variables. In conclusion, the Bacillus coagulans ‐based product evaluated was effective in improving some measures of quality of life and reducing gastrointestinal symptoms associated with intestinal‐related symptoms in otherwise healthy adults.