Effect of the consumption of a probiotic strain on the prevention of post-operative recurrence in Crohn's disease

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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