Crohn's DiseaseNCT01698970
Effect of the Consumption of a Probiotic Strain on the Prevention of Post-operative Recurrence in Crohn's Disease
A study testing 1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test) in people with Crohn's Disease, run by Danone Global Research & Innovation Center at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- 1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2004to Mar 2010
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Huriez - Service des maladies de l'appareil digestif et de la nutrition
Lille, 59037
About this study
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
- Crohn's Disease
- Being tested
- 1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test), 2- excipients (150 mg) in capsule (control)
- Keywords
- Probiotic, capsules, Crohn's disease, recurrent endoscopic ileo-colonic lesions
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test)Other
1- 6 test products/day
2- excipients (150 mg) in capsule (control)Other
2- 6 control poducts/day
| Study group | Role | What they receive |
|---|---|---|
| 1 = Tested product | Experimental | Not described Receives: Other: 1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test) |
| 2 = Control product | Placebo comparator | Not described Receives: Other: 2- excipients (150 mg) in capsule (control) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startFeb 2004
- Primary completionMar 2007
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698970
- Sponsor's protocol ID
- NU098
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2012
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No