Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedStudy Start
First participant enrolled
June 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 9, 2020
October 1, 2020
1.5 years
June 14, 2017
October 7, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (4)
Disease response- Crohn's disease patients
52 weeks
Disease response- ulcerative colitis patients
52 weeks
Biochemical remission
52 weeks
Biochemical remission
52 weeks
Study Arms (2)
Active
ACTIVE COMPARATOR4 gr Curcumin daily for 1 year in addition to vedolizumab 300 mg per infusion (standard of care)
Sham
PLACEBO COMPARATOR4 gr placebo daily for 1 year in addition to vedolizumab300 mg per infusion (standard of care)
Interventions
Eligibility Criteria
You may qualify if:
- Established inflammatory bowel disease
- Age ≥18 years old
- 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
You may not qualify if:
- CD- isolated small bowel disease (L1) UC- proctitis (E1)
- Perianal disease
- Pregnancy
- Biliary obstruction
- Concomitant treatment with beta blockers, anti-coagulants, and norfloxacin (relative contra indications to curcumin therapy).
- Curcumin supplementations within the last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henit Yanailead
- Shaare Zedek Medical Centercollaborator
Study Sites (1)
Rabin Medical Center
Petah Tikva, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of IBD center
Study Record Dates
First Submitted
June 14, 2017
First Posted
April 18, 2018
Study Start
June 9, 2020
Primary Completion
December 1, 2021
Study Completion
December 1, 2022
Last Updated
October 9, 2020
Record last verified: 2020-10