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Sponsors and Collaborators: |
University of North Carolina General Mills Inc. |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00618488 |
The purpose of this study is to determine if probiotics bacteria, specifically bifidobacterium lactis (BB12) improve gastrointestinal symptoms in subjects with functional gastrointestinal symptoms (i.e., non-patients IBS/functional bowel disorders).
Condition | Intervention |
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Pain |
Dietary Supplement: Probiotic BB12 - Bifidobacterium lactis Dietary Supplement: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Clinical Efficacy of Yogurt Containing Bifidobacterium Lactis (BB12) in Subjects With Functional Gastrointestinal Symptoms |
Enrollment: | 63 |
Study Start Date: | February 2007 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Bifidobacterium lactis
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Dietary Supplement: Probiotic BB12 - Bifidobacterium lactis
Bifidobacterium lactis (3.1 oz yogurt) administered once a day for 6 weeks
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2: Placebo Comparator
Placebo
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Dietary Supplement: Placebo
Placebo administered once a day for 6 weeks
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The apparent success of the use of probiotics in several gut disorders (e.g., IBD and rotavirus diarrhea) together with the greater understanding of the role of inflammation and intestinal microflora in the pathophysiology of functional bowel disorders has led to increased interest in use of probiotics in patients with these symptoms. The data on the use of probiotic in certain functional GI disorders (e.g., IBS, bloating, diarrhea) is limited but several reported studies show encouraging results and suggest some symptomatic response and parallel improvement in quality of life. Functional Bowel Disorders (FBD) - According to the Rome II criteria FBD refer to symptoms attributed to the mid or lower GI tract. FBD include several clinical subgroups including irritable bowel syndrome (IBS), functional diarrhea, functional constipation, functional abdominal bloating, and an unspecified group. This study will examine 'Non-Patients IBS,' these are people who have functional gastrointestinal (GI) symptoms but do not sought out medical care for their GI symptoms and therefore they are referred to as 'Non-patients'. This study will investigate the overall effect of probiotic bacteria (BB12) on GI symptoms in non-patients subjects with functional bowel symptoms (FBS).
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7080 |
Principal Investigator: | Yehuda Ringel, MD | The University of North Carolina, Chapel Hill |
Responsible Party: | Center for Digestive Diseases and Nutrition ( Yehuda Ringel M.D./Principal Investigator ) |
Study ID Numbers: | 06-0922 |
Study First Received: | February 7, 2008 |
Last Updated: | February 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00618488 |
Health Authority: | United States: Institutional Review Board |
Probiotics BB12 Gastrointestinal Symptoms |
Pain |