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Sponsors and Collaborators: |
Miami Research Associates Funded by Ganeden Biotech, Inc. Mayfield Heights, OH |
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Information provided by: | Miami Research Associates |
ClinicalTrials.gov Identifier: | NCT00881322 |
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.
Condition | Intervention |
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Abdominal Pain Abdominal Cramps Flatulence |
Dietary Supplement: BC-130 (Gas Defense) Dietary Supplement: Placebo |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 61 |
Study Start Date: | June 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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BC-130: Experimental
Active Arm
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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. |
Sugar Pill: Placebo Comparator
Placebo
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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 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subject has any of the following medical conditions:
United States, Florida | |
Miami Research Associates | |
Miami, Florida, United States, 33143 | |
Dominican Republic | |
Latin American Research | |
Santo Domingo, Dominican Republic |
Principal Investigator: | Diane Krieger, MD | Medical Director |
Responsible Party: | Miami Research Associates ( Diane Krieger, MD - Principal Investigator ) |
Study ID Numbers: | GAN-2008 |
Study First Received: | April 13, 2009 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00881322 History of Changes |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Silicon Signs and Symptoms, Digestive Abdominal Pain Colic |
Pain Healthy Flatulence Muscle Cramp |
Signs and Symptoms Signs and Symptoms, Digestive Abdominal Pain |
Colic Pain Flatulence |