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A Study on Intestinal Gas Symptoms to Evaluate the Effects of Gas Defense in Otherwise Healthy Adult

NCT00881322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2009-09-30

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

BC-130 (Gas Defense)

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.

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Ganeden Biotech, Inc.

    collaborator INDUSTRY

  • Miami Research Associates

    lead NETWORK

Principal Investigators

  • Diane Krieger, MD · Medical Director

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States
  • Dominican Republic

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00881322 on ClinicalTrials.gov