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

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ClinicalTrials.gov Identifier: NCT03500653
Recruitment Status : Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Shaare Zedek Medical Center
Information provided by (Responsible Party):
Henit Yanai, Rabin Medical Center

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.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Dietary Supplement: Curcumin Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active
4 gr Curcumin daily for 1 year in addition to vedolizumab 300 mg per infusion (standard of care)
Dietary Supplement: Curcumin
4 gr curcumin

Placebo Comparator: Sham
4 gr placebo daily for 1 year in addition to vedolizumab300 mg per infusion (standard of care)
Dietary Supplement: Placebo
4 gr placebo




Primary Outcome Measures :
  1. Clinical remission- Crohn's disease patients [ Time Frame: 52 weeks ]
    Crohn's disease patients - disease activity indexe: Harvey Bradshow index (HBI) less that 3

  2. Clinical remission- ulcerative colitis patients [ Time Frame: 52 weeks ]
    Disease activity index - partial Mayo score less than 2


Secondary Outcome Measures :
  1. Disease response- Crohn's disease patients [ Time Frame: 52 weeks ]
    Disease activity index- Harvey Bradshow index (HBI ) a drop of 3 points

  2. Disease response- ulcerative colitis patients [ Time Frame: 52 weeks ]
    Disease activity index -partial Mayo score a drop of 2 points

  3. Biochemical remission [ Time Frame: 52 weeks ]
    Fecal calprotectin less than 150 µg/gr

  4. Biochemical remission [ Time Frame: 52 weeks ]
    C reactive protein (CRP) less thn 0.5 mg/dl



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500653


Contacts
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Contact: Henit Yanai, MD +972-3977241 ext 5 henitya@clalit.org.il
Contact: Tamar Pfeffer-Gik, RD +972-50-8864740 tamarpf@clalit.org.il

Sponsors and Collaborators
Henit Yanai
Shaare Zedek Medical Center

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Responsible Party: Henit Yanai, Head of IBD center, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03500653     History of Changes
Other Study ID Numbers: RMC-0290-17
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Curcumin
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Vedolizumab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents