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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Curcumin
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Curcumin. Crohn's disease. Post-operative recurrence. Thiopurines . Rutgeerts endoscopic score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CURCUMIN

PLACEBO

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rutgeerts endoscopic score

Secondary Outcome Measures

CDAI score
Rutgeerts endoscopic score according to smoking status (yes/no)
Rutgeerts endoscopic score according to previous intestinal surgery (yes/no)
Rutgeerts endoscopic score according to anoperineal lesions (yes/no)
Rutgeerts endoscopic score according to a fistulising phenotype (yes/no)
Rutgeerts endoscopic score according to length of intestinal resection >0.5m

Full Information

First Posted
September 19, 2014
Last Updated
December 27, 2018
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
3i nature, Naturopôle Nutrition santé
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1. Study Identification

Unique Protocol Identification Number
NCT02255370
Brief Title
Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease
Acronym
POPCUR
Official Title
Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
3i nature, Naturopôle Nutrition santé

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Curcumin. Crohn's disease. Post-operative recurrence. Thiopurines . Rutgeerts endoscopic score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CURCUMIN
Arm Type
Experimental
Arm Description
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
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Curcumin
Other Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Rutgeerts endoscopic score
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
CDAI score
Time Frame
at 6 months and at 1 year
Title
Rutgeerts endoscopic score according to smoking status (yes/no)
Time Frame
at 6 months
Title
Rutgeerts endoscopic score according to previous intestinal surgery (yes/no)
Time Frame
at 6 months
Title
Rutgeerts endoscopic score according to anoperineal lesions (yes/no)
Time Frame
at 6 months
Title
Rutgeerts endoscopic score according to a fistulising phenotype (yes/no)
Time Frame
at 6 months
Title
Rutgeerts endoscopic score according to length of intestinal resection >0.5m
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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