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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698970
• Other study ID #: NU098
• Status: Completed
• Phase: N/A
• First received: October 1, 2012
• Last updated: December 6, 2016
• Start date: February 2004
• Est. completion date: March 2010

Study information

• Verified date: December 2016
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 2010
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Recurrence

Intervention

Other:
• 1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test)
1- 6 test products/day
• 2- excipients (150 mg) in capsule (control)
2- 6 control poducts/day

Locations

Country	Name	City	State
France	Hôpital Huriez - Service des maladies de l'appareil digestif et de la nutrition	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

France,