Crohn's Disease
Conditions
Keywords
Curcumin. Crohn's disease. Post-operative recurrence. Thiopurines . Rutgeerts endoscopic score
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.
Interventions
DRUGCurcumin
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
Sponsors
University Hospital, Clermont-Ferrand
3i nature
Naturopôle Nutrition santé
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rutgeerts endoscopic score | at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 previous intestinal surgery (yes/no) | at 6 months |
| Rutgeerts endoscopic score according to anoperineal lesions (yes/no) | at 6 months |
| Rutgeerts endoscopic score according to a fistulising phenotype (yes/no) | at 6 months |
| Rutgeerts endoscopic score according to length of intestinal resection >0.5m | at 6 months |
Countries
France
Outcome results
None listed