CClinicalTrials.gg
CompletedNCT01698970Updated Dec 7, 2016

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

An interventional study of 1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test) and 2- excipients (150 mg) in capsule (control) in Crohn's Disease, sponsored by Danone Global Research & Innovation Center. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-07.

Sponsored by Danone Global Research & Innovation Center · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Crohn's Disease

Keywords

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

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 122 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Danone Global Research & Innovation Center is the lead sponsor of 38 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    1 = Tested product

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

  • Placebo comparator
    2 = Control product

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

Interventions

  • Other1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test)

    1- 6 test products/day

  • Other2- excipients (150 mg) in capsule (control)

    2- 6 control poducts/day

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Study locations

1 site
  • Hôpital Huriez - Service des maladies de l'appareil digestif et de la nutrition
    Lille, 59037, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01698970
Lead sponsor
Danone Global Research & Innovation Center
Responsible party
Sponsor
First posted
Oct 3, 2012
Start date
Feb 2004
Primary completion
Mar 2007
Completion
Mar 2010
Last update
Dec 7, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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