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

University Hospital, Clermont-Ferrand

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT02255370

CHU-0207

2014-000261-51 (EudraCT Number)

Details and patient eligibility

About

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.

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

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups, including a placebo group

CURCUMIN

Experimental group

Description:

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

Treatment:

Drug: Curcumin

PLACEBO

Placebo Comparator group

Description:

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

Treatment:

Drug: Curcumin