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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03500653
• Other study ID #: RMC-0290-17
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: December 2022

Study information

• Verified date: October 2020
• Source: Rabin Medical Center
• Contact: Henit Yanai, MD
• Phone: +972-3977241
• Email: henitya[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Dietary Supplement:
• Curcumin
4 gr curcumin
• Placebo
4 gr placebo

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah tikva

Sponsors (2)

Lead Sponsor	Collaborator
Henit Yanai	Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission- Crohn's disease patients	Crohn's disease patients - disease activity indexe: Harvey Bradshow index (HBI) less that 3	52 weeks
Primary	Clinical remission- ulcerative colitis patients	Disease activity index - partial Mayo score less than 2	52 weeks
Secondary	Disease response- Crohn's disease patients	Disease activity index- Harvey Bradshow index (HBI ) a drop of 3 points	52 weeks
Secondary	Disease response- ulcerative colitis patients	Disease activity index -partial Mayo score a drop of 2 points	52 weeks
Secondary	Biochemical remission	Fecal calprotectin less than 150 µg/gr	52 weeks
Secondary	Biochemical remission	C reactive protein (CRP) less thn 0.5 mg/dl	52 weeks