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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02255370
• Date of registration: 19/09/2014
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Clermont-Ferrand
• Public title: Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease POPCUR
• Scientific title: Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease
• Date of first enrolment: December 2014
• Target sample size: 61
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02255370
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

France

Key inclusion & exclusion 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-TNFa treatment

- Concomitant treatment including antibiotics, probiotics, mesalazine, methotrexate,
cyclosporine, tacrolimus, anti-TNFa, 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Curcumin

Primary Outcome(s)

Rutgeerts endoscopic score [Time Frame: at 6 months]

Secondary Outcome(s)

Rutgeerts endoscopic score according to anoperineal lesions (yes/no) [Time Frame: at 6 months]

Rutgeerts endoscopic score according to smoking status (yes/no) [Time Frame: at 6 months]

CDAI score [Time Frame: at 6 months and at 1 year]

Rutgeerts endoscopic score according to previous intestinal surgery (yes/no) [Time Frame: at 6 months]

Rutgeerts endoscopic score according to a fistulising phenotype (yes/no) [Time Frame: at 6 months]

Rutgeerts endoscopic score according to length of intestinal resection >0.5m [Time Frame: at 6 months]

Secondary ID(s)

CHU-0207

2014-000261-51

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Naturopôle Nutrition santé

3i nature