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NCT00561535 Clinical Trial

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

Irritable Bowel Syndrome Clinical Trial

Official title:
Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00561535
Other study ID # AEFD 2007-01
Secondary ID
Status Completed
Phase Phase 2
First received November 20, 2007
Last updated January 26, 2011
Start date October 2007
Est. completion date June 2010

Study information
Verified date January 2011
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 60
Est. completion date June 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Lactobacillus FARCIMINIS
10.10 UFC of lactobacillus FARCIMINIS
• placebo (starch)
Once daily

Locations
Country Name City State
France Hopital Louis Mourier, GI Unit Colombes Ile de France

Sponsors (2)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Association pour l'Etude des Fonctions Digestives

Country where clinical trial is conducted

France, 

References & Publications (1)

Camilleri M, Chang L. Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles. Gastroenterology. 2008 Dec;135(6):1877-91. doi: 10.1053/j.gastro.2008.09.005. Epub 2008 Oct 9. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Overall subject's assessment 4 weeks Yes
Secondary 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 Yes
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