Effect of the Consumption of a Probiotic Strain on the Prevention of Post-operative Recurrence in… (NCT01698970) | Clinical Trial Compass
CompletedNot Applicable
Effect of the Consumption of a Probiotic Strain on the Prevention of Post-operative Recurrence in Crohn's Disease
France122 participantsStarted 2004-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.