Status:
COMPLETED
Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
3i nature
Naturopôle Nutrition santé
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Curcumin, the active ingredient of turmeric, has been used for long term in the treatment of inflammatory conditions. Inhibition of NF-κB is postulated as the main mechanism responsible for the anti-i...
Detailed Description
122 subjects, operated on for Crohn disease, will be included in the study. After ileo-colonic resection, subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d ...
Eligibility Criteria
Inclusion
- Crohn's disease confirmed by radiographic, endoscopic or histologic criteria
- Age \> 18 yr
- Affiliated to french health insurance
- Operated on less than 15 days ago for ileal, colonic or ileo-colonic Crohn's disease with all macroscopic lesions being removed, with an anastomosis which can be reached by ileocolonoscopy
Exclusion
- Ulcerative colitis
- Pregnant or nursing woman
- Refusal of contraceptive measure for childbearing potential, woman or fertile man
- Indication of anti-TNFα treatment
- Concomitant treatment including antibiotics, probiotics, mesalazine, methotrexate, cyclosporine, tacrolimus, anti-TNFα, ustekinumab, vedolizumab
- Concomitant treatment with corticosteroids, except in case of tapering a treatment initiated before surgery
- Renal insufficiency ( serum creatinine 2N)
- Chronic hepatic disease except for primary sclerosing cholangitis
- ALAT , ASAT, alkaline phosphatases, or bilirubin \> 3N
- Current infection to HIV, HBV (except if HBV Ac positives), HCV
- Contraindication to thiopurines
- Unwillingness of the patient
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT02255370
Start Date
December 1 2014
End Date
June 1 2018
Last Update
December 28 2018
Active Locations (1)
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1
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003