Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarr... | NCT00561535

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

NCT00561535

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jan 27, 2011Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Irritable Bowel Syndrome

Interventions

Lactobacillus FARCIMINIS
placebo (starch)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

May 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Nov 20, 2007

First Submission Date that Met QC Criteria

Nov 20, 2007

First Posted Date

Nov 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2011

Last Update Posted Date

Jan 27, 2011Estimated

Name	Class
Association pour l'Etude des Fonctions Digestives	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Lactobacillus FARCIMINIS	Dietary Supplement: Lactobacillus FARCIMINIS
B	Placebo Comparator	Placebo	Dietary Supplement: placebo (starch)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactobacillus FARCIMINIS	Dietary Supplement	10.10 UFC of lactobacillus FARCIMINIS	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall subject's assessment		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benoit Coffin, Prof	Assistance Publique - Hôpitaux de Paris	Principal Investigator
Yoram Bouhnik, Prof	Assistance Publique - Hôpitaux de Paris	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Louis Mourier, GI Unit		Colombes	Île-de-France Region	92700	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18848833	Background	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.

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D043183	Irritable Bowel Syndrome
D003967	Diarrhea