This is a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of Digestive Advantage™ Gas Defense formula, a probiotic dietary supplement. The study will last approximately four weeks, and subjects will be seen at a screening/randomization visit, and two follow-up visits. Study procedures will include administering questionnaires for assessment of the study product's effect on intestinal gas symptoms and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
61
Product Dosing: Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food) Gas Defense Serving Size: 1 tablet Active Ingredients: B. Coagulans, Enzyme Blend (Cellulase - Trichoderma longibrachiatum, Cellulase - Aspergillus niger, Hemicellulase, Alpha Galactosidase, Invertase) Inactive Ingredients: vegetable capsule, Magnesium Stearate, Silicon Dioxide, Maltodextrin Contains: Wheat, Fish.
Product Dosing: Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food) Placebo - matched in size and color to the active product Inactive Ingredients: microcrystalline cellulose, FD\&C yellow #5 Lake, FD\&C blue #1 Lake, FD\&C red #46 Lake and vegetable capsule
Miami Research Associates
Miami, Florida, United States
Latin American Research
Santo Domingo, Dominican Republic
To determine the effect of daily supplementation with GD as compared to placebo on intestinal gas symptoms as measured by the subscores of the GI Symptom Rating Scale (GSRS) and the subscores of the Severity of Dyspepsia Assessment (SODA).
Time frame: 4 weeks
Primary Safety Objective To determine if daily supplementation with GD is safe within the confines of this study as denoted by changes from baseline in blood pressure, heart rate, adverse events, and subjective remarks.
Time frame: 4 weeks
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