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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03500653
Recruitment Status : Not yet recruiting
First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Shaare Zedek Medical Center
Information provided by (Responsible Party):
Henit Yanai, Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE June 14, 2017
First Posted Date  ICMJE April 18, 2018
Last Update Posted Date April 18, 2018
Estimated Study Start Date  ICMJE July 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • Clinical remission- Crohn's disease patients [ Time Frame: 52 weeks ]
    Crohn's disease patients - disease activity indexe: Harvey Bradshow index (HBI) less that 3
  • Clinical remission- ulcerative colitis patients [ Time Frame: 52 weeks ]
    Disease activity index - partial Mayo score less than 2
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • Disease response- Crohn's disease patients [ Time Frame: 52 weeks ]
    Disease activity index- Harvey Bradshow index (HBI ) a drop of 3 points
  • Disease response- ulcerative colitis patients [ Time Frame: 52 weeks ]
    Disease activity index -partial Mayo score a drop of 2 points
  • Biochemical remission [ Time Frame: 52 weeks ]
    Fecal calprotectin less than 150 µg/gr
  • Biochemical remission [ Time Frame: 52 weeks ]
    C reactive protein (CRP) less thn 0.5 mg/dl
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab
Official Title  ICMJE Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Inflammatory Bowel Diseases
Intervention  ICMJE
  • Dietary Supplement: Curcumin
    4 gr curcumin
  • Dietary Supplement: Placebo
    4 gr placebo
Study Arms  ICMJE
  • Active Comparator: Active
    4 gr Curcumin daily for 1 year in addition to vedolizumab 300 mg per infusion (standard of care)
    Intervention: Dietary Supplement: Curcumin
  • Placebo Comparator: Sham
    4 gr placebo daily for 1 year in addition to vedolizumab300 mg per infusion (standard of care)
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Henit Yanai, MD +972-3977241 ext 5 henitya@clalit.org.il
Contact: Tamar Pfeffer-Gik, RD +972-50-8864740 tamarpf@clalit.org.il
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03500653
Other Study ID Numbers  ICMJE RMC-0290-17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Henit Yanai, Rabin Medical Center
Study Sponsor  ICMJE Henit Yanai
Collaborators  ICMJE Shaare Zedek Medical Center
Investigators  ICMJE Not Provided
PRS Account Rabin Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP