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| Name | Class |
|---|---|
| Shaare Zedek Medical Center | OTHER |
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Introduction: The pathogenesis of inflammatory bowel diseases (IBD) is characterized by dysregulation of the innate immune response it's associated with Th1, Th17 up-regulation, reflected by increased cytokine secretion including TNF-α. A main effective therapeutic interventions is blocking TNFα. Vedolizumab, an anti integrin, is a new class of treatment designed to block trafficking of lymphocytes in the gut. Clinical trials and real life experience response rates at week 6 range between 30-45%. Curcumin suppresses NFκβ levels via alteration of TLR2/4 pathways lowering TNF-α upstream. Curcumin is safe and efficacious in inducing response and remission in mild-moderate Ulcerative colitis (UC) and maintaining remission when used as an add-on to 5ASA derivatives, only with strict adherence to treatment overtime.
Objectives: Facing the low rate of response to therapies in IBD, the need for new treatments and the use of combination strategies lead us to believe that combining vedolizumab and curcumin may have a synergistic effect and will enable optimal immunomodulation.
Hypothesis: Concomitant oral curcumin in IBD patients with colonic involvement will augment remission rates as well as clinical and biochemical response.
Type of research and methods of data collection: A randomized controlled trial in 84 adults with colonic IBD (UC and CD). Eligible patients are during vedolizumab induction, patients will randomized will be into curcumin or placebo. Data will managed by investigators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | 4 gr Curcumin daily for 1 year in addition to vedolizumab 300 mg per infusion (standard of care) |
|
| Sham | Placebo Comparator | 4 gr placebo daily for 1 year in addition to vedolizumab300 mg per infusion (standard of care) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin | Dietary Supplement | 4 gr curcumin |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission- Crohn's disease patients | Crohn's disease patients - disease activity indexe: Harvey Bradshow index (HBI) less that 3 | 52 weeks |
| Clinical remission- ulcerative colitis patients | Disease activity index - partial Mayo score less than 2 | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease response- Crohn's disease patients | Disease activity index- Harvey Bradshow index (HBI ) a drop of 3 points | 52 weeks |
| Disease response- ulcerative colitis patients | Disease activity index -partial Mayo score a drop of 2 points |
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Inclusion Criteria:
Established inflammatory bowel disease
Age ≥18 years old
At inclusion all patients must have a documented active colonic involvement based on either endoscopy or imaging:
Commencing vedolizumab therapy according to the treating physician or on active therapy up to 6-weeks.
Active luminal disease:
CD- HBI ≥325, 26 UC- partial Mayo ≥227
Evident active disease on endoscopy or imaging within 2-week from inclusion or elevated inflammatory markers at screening (CRP> 0.5 mg/dl, or fecal calprotectin>100 μgr/gr stool or ESR >40).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henit Yanai, MD | Contact | +972-3977241 | 5 | henitya@clalit.org.il |
| Tamar Pfeffer-Gik, RD | Contact | +972-50-8864740 | tamarpf@clalit.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Recruiting | Petah Tikva | Israel |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| Dietary Supplement |
4 gr placebo |
|
| 52 weeks |
| Biochemical remission | Fecal calprotectin less than 150 µg/gr | 52 weeks |
| Biochemical remission | C reactive protein (CRP) less thn 0.5 mg/dl | 52 weeks |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |