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

Danone

Status

Completed

Conditions

Crohn's Disease

Treatments

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

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01698970

NU098

Details and patient eligibility

About

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.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No 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
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