Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03500653|
Recruitment Status : Not yet recruiting
First Posted : April 18, 2018
Last Update Posted : April 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Diseases||Dietary Supplement: Curcumin Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Active
4 gr Curcumin daily for 1 year in addition to vedolizumab 300 mg per infusion (standard of care)
Dietary Supplement: Curcumin
4 gr curcumin
Placebo Comparator: Sham
4 gr placebo daily for 1 year in addition to vedolizumab300 mg per infusion (standard of care)
Dietary Supplement: Placebo
4 gr placebo
- Clinical remission- Crohn's disease patients [ Time Frame: 52 weeks ]Crohn's disease patients - disease activity indexe: Harvey Bradshow index (HBI) less that 3
- Clinical remission- ulcerative colitis patients [ Time Frame: 52 weeks ]Disease activity index - partial Mayo score less than 2
- Disease response- Crohn's disease patients [ Time Frame: 52 weeks ]Disease activity index- Harvey Bradshow index (HBI ) a drop of 3 points
- Disease response- ulcerative colitis patients [ Time Frame: 52 weeks ]Disease activity index -partial Mayo score a drop of 2 points
- Biochemical remission [ Time Frame: 52 weeks ]Fecal calprotectin less than 150 µg/gr
- Biochemical remission [ Time Frame: 52 weeks ]C reactive protein (CRP) less thn 0.5 mg/dl
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500653
|Contact: Henit Yanai, MD||+972-3977241 ext firstname.lastname@example.org|
|Contact: Tamar Pfeffer-Gik, RDemail@example.com|