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

Last updated: December 27, 2018
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Completed

Phase

3

Condition

Inflammatory Bowel Disease

Colic

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

NCT02255370
CHU-0207
2014-000261-51
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 diseasewith all macroscopic lesions being removed, with an anastomosis which can be reachedby ileocolonoscopy

Exclusion

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 treatmentinitiated 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

Total Participants: 61
Study Start date:
December 01, 2014
Estimated Completion Date:
June 30, 2018

Study 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.

Connect with a study center

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003
    France

    Site Not Available

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