Efficacy of Probiotic Bacteria in Subjects With IBS or Functional Diarrhea/ Bloating

Pain Clinical Trial

Official title: Clinical Efficacy of Probiotic Bacteria in Subjects With Irritable Bowel Syndrome (IBS), Functional Diarrhea, or Functional Bloating

Status Completed

Clinical Trial Summary

To determine if probiotics bacteria, specifically lactobacillus and bifidobacterium, improve gastrointestinal symptoms in patients with IBS, functional diarrhea, or functional bloating.

Clinical Trial Description

Functional Bowel disorders (FBD) including Irritable Bowel Syndrome (IBS) are characterized by a variable combination of chronic or recurrent gastrointestinal symptoms not explained by structural or biochemical abnormalities. IBS is the most common functional gastrointestinal disorder, affecting 8% to 23% of adults in the western world and accounts for 12% of primary care and 28% of gastroenterological practice visits yearly. The pathophysiology of IBS is not completely understood and currently available drug treatments for IBS are very limited (1-2). The apparent success of the use of probiotics in several gut disorders (e.g., IBD) together with the greater understanding of the role of inflammation and intestinal microflora in the pathophysiology of IBS has led to increased interest in use of probiotics in patients with IBS (3). The data on the use of probiotic in IBS is limited. However, few reported studies show encouraging results and suggests some symptomatic response and parallel improvement in quality of life (3-4). A controlled, double-blind study, randomized 20 patients with IBS to L. plantarum 299v or placebo for 4 weeks concluded that L. plantarum decreased abdominal pain and tended to normalize stool frequency in constipated patients (5). On the other hand, Lactobacillus casei GG, was found to improve stool consistency in patients with IBS and diarrhea (6). A recent randomized controlled trial using the probiotic formulation VSL#3 improved abdominal bloating in patients with diarrhea-predominant IBS. However, no differences in gastrointestinal transit measurement, bowel function scores or satisfactory global symptom relief were shown (7). The inconsistent findings of these clinical studies may be accounted to the differences in probiotics composition and the heterogeneous and multifactorial nature of the disorder. However, these studies indicate a potential relationship between probiotics therapy and functional abdominal symptoms and suggesting that the possible role of probiotics in the treatment of IBS deserves further study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Pain

• NCT number: NCT00618904
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Completed
• Phase: N/A
• Start date: December 2005
• Completion date: September 2007