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

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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-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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: 3i nature; Naturopôle Nutrition santé
• Treatments: Curcumin

Criteria

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