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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Abdominal Pain
- Sponsor
- Miami Research Associates
- Enrollment
- 61
- Locations
- 2
- Primary Endpoint
- 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).
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is 18-75 years of age.
- •Subject self-reports at least one of the following symptoms after eating a meal or snack:
- •Abdominal pain/cramps
- •Distended feeling/bloating
- •Flatulence/gas
- •Subject is in otherwise general good health as determined by physical exam and medical history.
- •Subject is willing and able to comply with the protocol.
- •Female subjects not defined as post-menopausal (excluding hysterectomized and post bilateral tubal ligations) must use a reliable method of birth control as defined within this protocol.
- •Subject is able to understand and sign the informed consent (English or Spanish) to participate in the study.
Exclusion Criteria
- •Subject has any of the following medical conditions:
- •active heart disease
- •renal or hepatic impairment/disease
- •Type I or II diabetes
- •psychiatric disorders (hospitalized within the past one year)
- •bipolar disorder
- •Parkinson's disease
- •unstable thyroid disease
- •immune disorder (such as HIV/AIDS)
- •any medical condition deemed exclusionary by the Principal Investigator (PI)
Outcomes
Primary Outcomes
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