Clinical trial NCT03500653: Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab
Official title: Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Shaare Zedek Medical Center
First posted: 2018-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinical remission- Crohn's disease patients
timeFrame: 52 weeks
measure: Clinical remission- ulcerative colitis patients
timeFrame: 52 weeks
Secondary outcomes:
measure: Disease response- Crohn's disease patients
timeFrame: 52 weeks
measure: Disease response- ulcerative colitis patients
timeFrame: 52 weeks
measure: Biochemical remission
timeFrame: 52 weeks
measure: Biochemical remission
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References: