Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease
NCT ID: NCT02255370
Last Updated: 2018-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
61 participants
INTERVENTIONAL
2014-12-31
2018-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
PLACEBO
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
3i nature
OTHER
Naturopôle Nutrition santé
UNKNOWN
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-000261-51
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CHU-0207
Identifier Type: -
Identifier Source: org_study_id