Stelara and Diet Trial for Crohn"s Disease

Sponsor
Wolfson Medical Center
Study ID
NCT04779762
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Dietary therapy involving the Crohn's disease exclusion diet (CDED) is an evolving strategy to target the microbiome and innate immunity in order to reduce inflammation and promote healing. The goal of the current pilot study is to evaluate the added benefit of treatment with Ustekinumab combined with CDED in anti TNF exposed patients compared to treatment with Ustekinumab alone in term of achieving remission.

Key Dates

Start date
Jan 31, 2022
Status verified
Feb 2021
Primary completion
Jan 31, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Standard induction regimen of Ustekinumab with the Crohn's disease exclusion diet (CDED)
  • Active Comparator: Group 2
    Standard induction regimen of Ustekinumab as above without diet

Primary Outcome Measure

ITT, steroid free remission [ Time Frame: week 12 ]

Central Contacts

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