Crohn's DiseasePhase 3POPCURNCT02255370
Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease
A Phase 3 study testing Curcumin in people with Crohn's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Curcumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines 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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- Curcumin
- Keywords
- Curcumin. Crohn's disease. Post-operative recurrence. Thiopurines . Rutgeerts endoscopic score
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rutgeerts endoscopic score
Measured: at 6 months
Secondary outcomes (6)
CDAI score
Measured: at 6 months and at 1 year
Rutgeerts endoscopic score according to smoking status (yes/no)
Measured: at 6 months
Rutgeerts endoscopic score according to previous intestinal surgery (yes/no)
Measured: at 6 months
Rutgeerts endoscopic score according to anoperineal lesions (yes/no)
Measured: at 6 months
Rutgeerts endoscopic score according to a fistulising phenotype (yes/no)
Measured: at 6 months
Rutgeerts endoscopic score according to length of intestinal resection >0.5m
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- 3i nature, Naturopôle Nutrition santé
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255370
- Sponsor's protocol ID
- CHU-0207
- Other IDs
- 2014-000261-51, 2014
- Acronym
- POPCUR
- Status last verified
- Dec 2018
- First submitted
- 19 Sep 2014
- Last updated
- 20 May 2026
- Results posted
- No
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. 2020 Jun;18(7):1553-1560.e1. doi: 10.1016/j.cgh.2019.08.041. Epub 2019 Aug 27.
PubMed 31470175
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease
- ClinicalTrials.gov ID
- NCT02255370
- Acronym / sponsor ID
- POPCUR / CHU-0207
- Conditions
- Crohn's Disease
- Keywords
- Curcumin. Crohn's disease. Post-operative recurrence. Thiopurines . Rutgeerts endoscopic score
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- 3i nature, Naturopôle Nutrition santé
- Study start
- Dec 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CURCUMIN | Experimental | Drug: Curcuminsubjects 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 |
| PLACEBO | Placebo comparator | Drug: Curcuminsubjects 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminAlso: placebosubjects 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 |
Primary outcome
Rutgeerts endoscopic score
Time frame: at 6 months
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Results publication: PubMed 31470175Bommelaer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Curcumin in people with Crohn's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rutgeerts endoscopic score (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02255370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.