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

This study has been completed.
Sponsor:
Collaborator:
Association pour l'Etude des Fonctions Digestives
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00561535
First received: November 20, 2007
Last updated: January 26, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Dietary Supplement: Lactobacillus FARCIMINIS
Dietary Supplement: placebo (starch)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Overall subject's assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Decrease in abdominal pain, stool form and consistency, modifications in intestinal permeability, modification in fecal serine protease activity, modifications in interleukin seric concentrations [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: October 2007
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Lactobacillus FARCIMINIS
Dietary Supplement: Lactobacillus FARCIMINIS
10.10 UFC of lactobacillus FARCIMINIS
Other Name: 10.10 UFC of lactobacillus FARCIMINIS
Placebo Comparator: B
Placebo
Dietary Supplement: placebo (starch)
Once daily
Other Name: Once daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561535

Locations
France
Hopital Louis Mourier, GI Unit
Colombes, Ile de France, France, 92700
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Association pour l'Etude des Fonctions Digestives
Investigators
Principal Investigator: Benoit Coffin, Prof Assistance Publique - Hôpitaux de Paris
Study Director: Yoram Bouhnik, Prof Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: COFFIN, Association pour l'Etude des Fonctions Digestives
ClinicalTrials.gov Identifier: NCT00561535     History of Changes
Other Study ID Numbers: AEFD 2007-01
Study First Received: November 20, 2007
Last Updated: January 26, 2011
Health Authority: France: Direction Générale de la Santé

Keywords provided by Assistance Publique - Hôpitaux de Paris:
IBS
Diarrhea
Rome III

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014