NCT02255370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 20, 2026

Status Verified

December 1, 2018

Enrollment Period

2.9 years

First QC Date

September 19, 2014

Last Update Submit

May 18, 2026

Conditions

Crohn's Disease

Keywords

Curcumin. Crohn's disease. Post-operative recurrence. Thiopurines . Rutgeerts endoscopic score

Outcome Measures

Primary Outcomes (1)

  • Rutgeerts endoscopic score

    at 6 months

Secondary Outcomes (6)

  • CDAI score

    at 6 months and at 1 year

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

    at 6 months

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

    at 6 months

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

    at 6 months

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

    at 6 months

  • +1 more secondary outcomes

Study Arms (2)

CURCUMIN

EXPERIMENTAL

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

PLACEBO

PLACEBO COMPARATOR

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

Interventions

CurcuminDRUG

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

Also known as: placebo
CURCUMINPLACEBO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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. 2020 Jun;18(7):1553-1560.e1. doi: 10.1016/j.cgh.2019.08.041. Epub 2019 Aug 27.

    PMID: 31470175RESULT

MeSH Terms

Conditions

Crohn Disease

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2014

First Posted

October 2, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2017

Study Completion

June 1, 2018

Last Updated

May 20, 2026

Record last verified: 2018-12

Locations

FR(1)