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

University Hospital, Clermont-Ferrand61 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Crohn's Disease

Interventions

CurcuminDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Rutgeerts endoscopic score

Time frame: at 6 months

Secondary Outcomes

CDAI score

Time frame: at 6 months and at 1 year

Rutgeerts endoscopic score according to smoking status (yes/no)

Time frame: at 6 months

Rutgeerts endoscopic score according to previous intestinal surgery (yes/no)

Time frame: at 6 months

Rutgeerts endoscopic score according to anoperineal lesions (yes/no)

Time frame: at 6 months

Rutgeerts endoscopic score according to a fistulising phenotype (yes/no)

Time frame: at 6 months

Rutgeerts endoscopic score according to length of intestinal resection >0.5m

Time frame: at 6 months

Data from ClinicalTrials.gov

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