Clinical trial NCT02255370: Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease
Official title: Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Curcumin. Crohn's disease. Post-operative recurrence. Thiopurines . Rutgeerts endoscopic score
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: 3i nature
name: Naturopôle Nutrition santé
First posted: 2014-10-02
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Rutgeerts endoscopic score
timeFrame: at 6 months
Secondary outcomes:
measure: CDAI score
timeFrame: at 6 months and at 1 year
measure: Rutgeerts endoscopic score according to smoking status (yes/no)
timeFrame: at 6 months
measure: Rutgeerts endoscopic score according to previous intestinal surgery (yes/no)
timeFrame: at 6 months
measure: Rutgeerts endoscopic score according to anoperineal lesions (yes/no)
timeFrame: at 6 months
measure: Rutgeerts endoscopic score according to a fistulising phenotype (yes/no)
timeFrame: at 6 months
measure: Rutgeerts endoscopic score according to length of intestinal resection >0.5m
timeFrame: at 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
References: