Trials / Completed
CompletedNCT01698970
Effect of the Consumption of a Probiotic Strain on the Prevention of Post-operative Recurrence in Crohn's Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Danone Global Research & Innovation Center · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test) | 1- 6 test products/day |
| OTHER | 2- excipients (150 mg) in capsule (control) | 2- 6 control poducts/day |
Timeline
- Start date
- 2004-02-01
- Primary completion
- 2007-03-01
- Completion
- 2010-03-01
- First posted
- 2012-10-03
- Last updated
- 2016-12-07
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01698970. Inclusion in this directory is not an endorsement.