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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Consumption of a Probiotic Strain on the Prevention of Post-operative Recurrence in Crohn's Disease
- ClinicalTrials.gov ID
- NCT01698970
- Acronym / sponsor ID
- NU098
- Conditions
- Crohn's Disease
- Keywords
- Probiotic, capsules, Crohn's disease, recurrent endoscopic ileo-colonic lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 = Tested product | Experimental | Other: 1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test) |
| 2 = Control product | Placebo comparator | Other: 2- excipients (150 mg) in capsule (control) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test)1- 6 test products/day | Other | 1 = Tested product |
| 2- excipients (150 mg) in capsule (control)2- 6 control poducts/day | Other | 2 = Control product |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.