Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS Patients

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT00561535
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Probiotics may improve symptoms in IBS patients. The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.

Detailed Description

The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-26
• Last Update Posted: 2011-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diarrhea predominant IBS
• Less than 5-year duration
• Pain intensity between 2 and 7 on VAS

Exclusion Criteria

• Celiac disease
• Antibiotic treatment within the 1-month period preceding inclusion
• Digestive organic disease
• Any severe non digestive organic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall subject's assessment	4 weeks

Secondary Outcome Measures

Name	Time	Method
Decrease in abdominal pain, stool form and consistency, modifications in intestinal permeability, modification in fecal serine protease activity, modifications in interleukin seric concentrations	4 weeks

Trial Locations

Locations (1)

Hopital Louis Mourier, GI Unit; 🇫🇷 Colombes, Ile de France, France