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

This study has been completed.
Sponsor:
Collaborator:
Prof. Pierre DESREUMAUX
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01698970
First received: October 1, 2012
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Crohn's Disease
Other: 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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Effect of the Consumption of a Probiotic Strain on the Prevention of Post-operative Recurrence in Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Danone Research:

Enrollment: 122
Study Start Date: February 2004
Study Completion Date: March 2010
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698970

Locations
France
Hôpital Huriez - Service des maladies de l'appareil digestif et de la nutrition
Lille, France, 59037
Sponsors and Collaborators
Danone Research
Prof. Pierre DESREUMAUX
  More Information

No publications provided

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01698970     History of Changes
Other Study ID Numbers: NU098
Study First Received: October 1, 2012
Last Updated: October 2, 2012
Health Authority: France: Direction Générale de la Santé

Keywords provided by Danone Research:
Probiotic
capsules
Crohn's disease
recurrent endoscopic ileo-colonic lesions

Additional relevant MeSH terms:
Recurrence
Crohn Disease
Disease Attributes
Pathologic Processes
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014