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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000261-51 | EudraCT Number |
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| Name | Class |
|---|---|
| 3i nature | OTHER |
| Naturopôle Nutrition santé | UNKNOWN |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rutgeerts endoscopic score | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31470175 | Result | 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. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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|
| 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 |
| Rutgeerts endoscopic score according to length of intestinal resection >0.5m | at 6 months |
| D007410 | Intestinal Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |