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Trial record 10 of 168 for:    curcumin

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 : Recruiting
First Posted : October 2, 2014
Last Update Posted : July 26, 2016
Sponsor:
Collaborators:
3i nature
Naturopôle Nutrition santé
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Curcumin Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease
Study Start Date : December 2014
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
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
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
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
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



Primary Outcome Measures :
  1. Rutgeerts endoscopic score [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255370


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Gilles BOMMELAER         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
3i nature
Naturopôle Nutrition santé

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02255370     History of Changes
Other Study ID Numbers: CHU-0207
2014-000261-51 ( EudraCT Number )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Curcumin. Crohn's disease. Post-operative recurrence. Thiopurines . Rutgeerts endoscopic score

Additional relevant MeSH terms:
Curcumin
Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action