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

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ClinicalTrials.gov Identifier: NCT02255370
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : December 28, 2018
Sponsor:
Collaborators:
3i nature
Naturopôle Nutrition santé
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date  ICMJE September 19, 2014
First Posted Date  ICMJE October 2, 2014
Last Update Posted Date December 28, 2018
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2014)
Rutgeerts endoscopic score [ Time Frame: at 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02255370 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2014)
  • CDAI score [ Time Frame: at 6 months and at 1 year ]
  • Rutgeerts endoscopic score according to smoking status (yes/no) [ Time Frame: at 6 months ]
  • Rutgeerts endoscopic score according to previous intestinal surgery (yes/no) [ Time Frame: at 6 months ]
  • Rutgeerts endoscopic score according to anoperineal lesions (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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease
Official Title  ICMJE Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE 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
Other Name: placebo
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Drug: Curcumin
  • Placebo Comparator: 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
    Intervention: Drug: Curcumin
Publications * Bommelaer G, Laharie D, Nancey S, Hebuterne X, Roblin X, Nachury M, Peyrin-Biroulet L, Fumery M, Richard D, Pereira B, Goutte M, Buisson A; POPCUR study group. Oral Curcumin No More Effective Than Placebo in Preventing Recurrence of Crohn's Disease After Surgery in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2019 Aug 27. pii: S1542-3565(19)30916-4. doi: 10.1016/j.cgh.2019.08.041. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 27, 2018)
61
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2014)
122
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02255370
Other Study ID Numbers  ICMJE CHU-0207
2014-000261-51 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE
  • 3i nature
  • Naturopôle Nutrition santé
Investigators  ICMJE Not Provided
PRS Account University Hospital, Clermont-Ferrand
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP