Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease

Study Overview
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Brief Summary
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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-inflammatory effect of curcumin Aim : to study the effect of curcumin, 3g per day, as compared to placebo, combined with thiopurines in the prevention of Crohn's disease post-operative recurrence.

Detailed Description
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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 per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria.

Official Title
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Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Curcumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CURCUMIN<br>subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria | Drug: Curcumin<br>* subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria<br>* Other names: placebo;|
| Placebo Comparator: PLACEBO<br>subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria | Drug: Curcumin<br>* subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rutgeerts endoscopic score |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDAI score |  | at 6 months and at 1 year | 
| Rutgeerts endoscopic score according to smoking status (yes/no) |  | at 6 months | 
| Rutgeerts endoscopic score according to previous intestinal surgery (yes/no) |  | at 6 months | 
| Rutgeerts endoscopic score according to anoperineal lesions (yes/no) |  | at 6 months | 
| Rutgeerts endoscopic score according to a fistulising phenotype (yes/no) |  | at 6 months | 
| Rutgeerts endoscopic score according to length of intestinal resection >0.5m |  | at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curcumin. Crohn's disease. Post-operative recurrence. Thiopurines . Rutgeerts endoscopic score