Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS Patients
Phase 2
Completed
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Dietary Supplement: Lactobacillus FARCIMINISDietary Supplement: placebo (starch)
- 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.
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
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Exclusion Criteria
- Celiac disease
- Antibiotic treatment within the 1-month period preceding inclusion
- Digestive organic disease
- Any severe non digestive organic disease
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Lactobacillus FARCIMINIS Lactobacillus FARCIMINIS B placebo (starch) Placebo
- 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