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

NCT01698970 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2016-12-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Danone Global Research & Innovation Center

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2007-03-31
Completion
2010-03-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01698970 on ClinicalTrials.gov