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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Lactobacillus FARCIMINIS
placebo (starch)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, Diarrhea, Rome III

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Louis Mourier, GI Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Lactobacillus FARCIMINIS

Placebo

Outcomes

Primary Outcome Measures

Overall subject's assessment

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

Full Information

First Posted
November 20, 2007
Last Updated
January 26, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Association pour l'Etude des Fonctions Digestives
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1. Study Identification

Unique Protocol Identification Number
NCT00561535
Brief Title
Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS Patients
Official Title
Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Association pour l'Etude des Fonctions Digestives

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
IBS, Diarrhea, Rome III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Lactobacillus FARCIMINIS
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus FARCIMINIS
Other Intervention Name(s)
10.10 UFC of lactobacillus FARCIMINIS
Intervention Description
10.10 UFC of lactobacillus FARCIMINIS
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo (starch)
Other Intervention Name(s)
Once daily
Intervention Description
Once daily
Primary Outcome Measure Information:
Title
Overall subject's assessment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoit Coffin, Prof
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoram Bouhnik, Prof
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Louis Mourier, GI Unit
City
Colombes
State/Province
Ile de France
ZIP/Postal Code
92700
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18848833
Citation
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.
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Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS Patients

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