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

NCT ID: NCT01698970

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn's Disease

Keywords

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Probiotic capsules Crohn's disease recurrent endoscopic ileo-colonic lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 = Tested product

Group Type EXPERIMENTAL

1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test)

Intervention Type OTHER

1- 6 test products/day

2 = Control product

Group Type PLACEBO_COMPARATOR

2- excipients (150 mg) in capsule (control)

Intervention Type OTHER

2- 6 control poducts/day

Interventions

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1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test)

1- 6 test products/day

Intervention Type OTHER

2- excipients (150 mg) in capsule (control)

2- 6 control poducts/day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Huriez - Service des maladies de l'appareil digestif et de la nutrition

Lille, , France

Site Status

Countries

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France

Other Identifiers

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NU098

Identifier Type: -

Identifier Source: org_study_id