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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Rabin Medical Center
Petah Tikva, Israel
RECRUITINGClinical remission- Crohn's disease patients
Crohn's disease patients - disease activity indexe: Harvey Bradshow index (HBI) less that 3
Time frame: 52 weeks
Clinical remission- ulcerative colitis patients
Disease activity index - partial Mayo score less than 2
Time frame: 52 weeks
Disease response- Crohn's disease patients
Disease activity index- Harvey Bradshow index (HBI ) a drop of 3 points
Time frame: 52 weeks
Disease response- ulcerative colitis patients
Disease activity index -partial Mayo score a drop of 2 points
Time frame: 52 weeks
Biochemical remission
Fecal calprotectin less than 150 µg/gr
Time frame: 52 weeks
Biochemical remission
C reactive protein (CRP) less thn 0.5 mg/dl
Time frame: 52 weeks
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