NCT00618488

Efficacy of Yogurt Containing BB12 in Subjects With GI Symptoms

Clinical Efficacy of Yogurt Containing Bifidobacterium Lactis (BB12) in Subjects With Functional Gastrointestinal Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: University of North Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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).

Conditions

• Pain

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic BB12 - Bifidobacterium lactis	Bifidobacterium lactis (3.1 oz yogurt) administered once a day for 6 weeks
DIETARY_SUPPLEMENT	Placebo	Placebo administered once a day for 6 weeks

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2008-02-20
• Last updated: 2008-02-20

Locations

1 site across 1 country: United States