Inflammatory Bowel Diseases
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCurcumin
4 gr curcumin
DIETARY_SUPPLEMENTPlacebo
4 gr placebo
Sponsors
Shaare Zedek Medical Center
Henit Yanai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Established inflammatory bowel disease 2. Age ≥18 years old 3. At inclusion all patients must have a documented active colonic involvement based on either endoscopy or imaging: 4. Commencing vedolizumab therapy according to the treating physician or on active therapy up to 6-weeks. 5. Active luminal disease: CD- HBI ≥325, 26 UC- partial Mayo ≥227 6. 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
1. CD- isolated small bowel disease (L1) UC- proctitis (E1) 2. Perianal disease 3. Pregnancy 4. Biliary obstruction 5. Concomitant treatment with beta blockers, anti-coagulants, and norfloxacin (relative contra indications to curcumin therapy). 6. Curcumin supplementations within the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission- Crohn's disease patients | 52 weeks | Crohn's disease patients - disease activity indexe: Harvey Bradshow index (HBI) less that 3 |
| Clinical remission- ulcerative colitis patients | 52 weeks | Disease activity index - partial Mayo score less than 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease response- Crohn's disease patients | 52 weeks | Disease activity index- Harvey Bradshow index (HBI ) a drop of 3 points |
| Disease response- ulcerative colitis patients | 52 weeks | Disease activity index -partial Mayo score a drop of 2 points |
| Biochemical remission | 52 weeks | Fecal calprotectin less than 150 µg/gr |
Countries
Israel
Contacts
Primary ContactHenit Yanai, MD
Backup ContactTamar Pfeffer-Gik, RD
Outcome results
None listed