Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab

NCT ID: NCT03500653

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-09
• Study Completion Date: 2022-12-31

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

4 gr Curcumin daily for 1 year in addition to vedolizumab 300 mg per infusion (standard of care)

Group Type: ACTIVE_COMPARATOR

Curcumin

Intervention Type: DIETARY_SUPPLEMENT

4 gr curcumin

Sham

4 gr placebo daily for 1 year in addition to vedolizumab300 mg per infusion (standard of care)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

4 gr placebo

Interventions

Curcumin

4 gr curcumin

Intervention Type: DIETARY_SUPPLEMENT

Placebo

4 gr placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: collaborator

Henit Yanai

OTHER

Sponsor Role: lead

Responsible Party

Henit Yanai

Head of IBD center

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Rabin Medical Center

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Henit Yanai, MD

Role: CONTACT

henitya@clalit.org.il

+972-3977241 ext. 5

Tamar Pfeffer-Gik, RD

Role: CONTACT

tamarpf@clalit.org.il

+972-50-8864740

Facility Contacts

Henit Yanai, MD

Role: primary

Tamar Pfefer Gic, MA

Role: backup

Other Identifiers

RMC-0290-17

Identifier Type: -

Identifier Source: org_study_id