Inflammatory Bowel Diseases Clinical Trial
Official title:
Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab
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.
n/a
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