NCT00561535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 27, 2011

Status Verified

January 1, 2011

Enrollment Period

2.6 years

First QC Date

November 20, 2007

Last Update Submit

January 26, 2011

Conditions

Irritable Bowel Syndrome

Keywords

IBSDiarrheaRome III

Outcome Measures

Primary Outcomes (1)

  • Overall subject's assessment

    4 weeks

Secondary Outcomes (1)

  • 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

Study Arms (2)

A

EXPERIMENTAL

Lactobacillus FARCIMINIS

Dietary Supplement: Lactobacillus FARCIMINIS

B

PLACEBO COMPARATOR

Placebo

Dietary Supplement: placebo (starch)

Interventions

Lactobacillus FARCIMINISDIETARY_SUPPLEMENT

10.10 UFC of lactobacillus FARCIMINIS

Also known as: 10.10 UFC of lactobacillus FARCIMINIS
A
placebo (starch)DIETARY_SUPPLEMENT

Once daily

Also known as: Once daily
B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Celiac disease
  • Digestive organic disease
  • Any severe non digestive organic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Louis Mourier, GI Unit

Colombes, Île-de-France Region, 92700, France

Location

Related 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.

    PMID: 18848833BACKGROUND

MeSH Terms

Conditions

Irritable Bowel SyndromeDiarrhea

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benoit Coffin, Prof

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Yoram Bouhnik, Prof

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 21, 2007

Study Start

October 1, 2007

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

January 27, 2011

Record last verified: 2011-01

Locations

FR(1)