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Completed

NCT Number: NCT02255370

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

curcumin

Drug

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 names: placebo

Primary outcomes

  1. Rutgeerts endoscopic score

    Time frame: at 6 months

Secondary outcomes

  1. CDAI score

    Time frame: at 6 months and at 1 year

  2. Rutgeerts endoscopic score according to smoking status (yes/no)

    Time frame: at 6 months

  3. Rutgeerts endoscopic score according to previous intestinal surgery (yes/no)

    Time frame: at 6 months

  4. Rutgeerts endoscopic score according to anoperineal lesions (yes/no)

    Time frame: at 6 months

  5. Rutgeerts endoscopic score according to a fistulising phenotype (yes/no)

    Time frame: at 6 months

  6. Rutgeerts endoscopic score according to length of intestinal resection >0.5m

    Time frame: at 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • 3i nature
  • Naturopôle Nutrition santé

Registry information

Official study title

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

Acronym: POPCUR

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Oct 2, 2014
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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