Clinical Trial: A Study on Intestinal Gas Symptoms to Evaluate the Effects of Gas Defense in Otherwise Healthy Adult
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Clinical Trial to Evaluate the Effects of Gas Defense On Intestinal Gas Symptoms in Otherwise Healthy Adults
Brief Summary:
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.
Detailed Summary:
Sponsor: Miami Research Associates
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Miami Research Associates
Dates:
Date Received: April 13, 2009
Date Started: June 2008
Date Completion:
Last Updated: September 29, 2009
Last Verified: September 2009
