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

Phase 3

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: Curcumin

• Registration Number: NCT02255370
• Lead Sponsor: University Hospital, Clermont-Ferrand

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-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

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 Timeline

• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-02
• Study Start: 2014-12
• Primary Completion: 2017-11
• Study Completion: 2018-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-27
• Last Update Posted: 2018-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CURCUMIN	Curcumin	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
PLACEBO	Curcumin	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

Primary Outcome Measures

Name	Time	Method
Rutgeerts endoscopic score	at 6 months

Secondary Outcome Measures

Name	Time	Method
Rutgeerts endoscopic score according to a fistulising phenotype (yes/no)	at 6 months
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 anoperineal lesions (yes/no)	at 6 months
Rutgeerts endoscopic score according to previous intestinal surgery (yes/no)	at 6 months
Rutgeerts endoscopic score according to length of intestinal resection >0.5m	at 6 months

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France