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COMPLETEDNA

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

NCT01698970•Danone Global Research & Innovation Center

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (1)

Hôpital Huriez - Service des maladies de l'appareil digestif et de la nutrition

Lille, France

Key Dates

Start Date

February 1, 2004

Primary Completion Date

March 1, 2007

Completion Date

March 1, 2010

Last Updated

December 7, 2016

Enrollment

122

ACTUAL participants

Conditions

Crohn's Disease

Interventions

1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test)

OTHER

2- excipients (150 mg) in capsule (control)

OTHER

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

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Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 7, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

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Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease