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

Crohn's Disease Clinical Trial

— POPCUR  

Official title:

Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255370
• Other study ID #: CHU-0207
• Secondary ID: 2014-000261-51
• Status: Completed
• Phase: Phase 3
• Start date: December 2014
• Est. completion date: June 2018

Study information

• Verified date: December 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Recurrence

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	3i nature, Naturopôle Nutrition santé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rutgeerts endoscopic score		at 6 months
Secondary	CDAI score		at 6 months and at 1 year
Secondary	Rutgeerts endoscopic score according to smoking status (yes/no)		at 6 months
Secondary	Rutgeerts endoscopic score according to previous intestinal surgery (yes/no)		at 6 months
Secondary	Rutgeerts endoscopic score according to anoperineal lesions (yes/no)		at 6 months
Secondary	Rutgeerts endoscopic score according to a fistulising phenotype (yes/no)		at 6 months
Secondary	Rutgeerts endoscopic score according to length of intestinal resection >0.5m		at 6 months