Effect of the Consumption of a Probiotic Strain on the Prevention of Post-operative Recurrence in Crohn's Disease

December 6, 2016 updated by: Danone Research
A double-blind, multicentre, stratified by centre, randomised, parallel study with two groups of adult patients operated on for Crohn's disease, to determine if oral ingestion of probiotics could prevent the appearance of Crohn's disease recurrent endoscopic ileo-colonic lesions 12 months after surgery. Patients will consume 900 mg/day of active product (N=56) or control product (N=56) during one year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Hôpital Huriez - Service des maladies de l'appareil digestif et de la nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male/female at least 18 years old
  • Diagnosis of Crohn's disease defined by the criteria usually adopted (Gower-Rousseau, 1994)
  • Crohn's disease mainly limited to the terminal ileum and/or the ascending and transverse colon
  • Diagnosis of Crohn's disease in agreement with surgical specimen analysis
  • Patient having given its written consent to take part in the study
  • Complete resection of all main macroscopic ileo-colonic lesions, as shown by inspection at surgery
  • To have an ileo-colic resection (right, transverse, left) with an anastomosis that can be inspected by endoscopy
  • Ability to start oral nutrition and therefore the consumption of the study product within 21 days of surgery
  • Patient receiving no antibiotics at the beginning of the product consumption

Exclusion Criteria:

  • One or more intestinal resection during the 5 last years before the last surgery
  • Presence of any severe additional disease
  • For female patient : pregnancy or breast feeding
  • For pre-menopausal female patient : no effective contraceptive methods used (combined oestrogen-progestogen pill or Intrauterine Device)
  • Patient currently in an exclusion period following participation in another clinical trial
  • Patient in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the patient
  • Significant presence of Crohn's disease in other intestinal tracts
  • Small bowel cumulative resection exceeding 1 meter
  • Patient with ileostomy
  • Subtotal colectomy with ileo-rectal anastomosis
  • Severe post-operative septic complications (fistula, peritonitis), leading to administration of more than 15 days of post-operative antibiotherapy)
  • Intake of unauthorised treatments (mesalazine, olsalazine or sulfasalazine, 5-Aminosalicylates (5-ASA) or 4-Aminosalicylates (4-ASA)) ; corticoïds and immunosuppressors) after surgery except corticoids which will have to be stopped within 6 weeks after surgery according to standardised stepwise dose reductions
  • Patient under artificial nutrition
  • Subject with a loss of personal liberty, by administrative or judicial decision, or major with a legal guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 = Tested product
Other: 1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test)
1- 6 test products/day
Placebo Comparator: 2 = Control product
Other: 2- excipients (150 mg) in capsule (control)
2- 6 control poducts/day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danone Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn's Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe