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Stelara and Diet Trial for Crohn"s Disease

NCT04779762 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-03-03

No results posted yet for this study

Summary

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.

Conditions

  • Crohn Disease

Interventions

OTHER

Crohn's disease exclusion diet (CDED)

Dietary therapy for Crohn's disease

DRUG

Ustekinumab Injection [Stelara]

Drug for Crohn's disease

Sponsors & Collaborators

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Wolfson Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2025-01-31
Completion
2026-01-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04779762 on ClinicalTrials.gov