Real-life Use of the Crohn's Disease Exclusion Diet (CDED) in Adult Patients With Crohn's Disease

Last updated: June 3, 2024
Sponsor: Universita degli Studi di Genova
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Diet

Clinical Study ID

NCT06448819
CDED-1
  • Ages 18-80
  • All Genders

Study Summary

This study explores the effectiveness od the Crohn's Disease Exclusion Diet (CDED) as a tretament for adults with mild-to-moderate Crohn's disease (CD). The hypotesis is that CDED, by excluding specific dietary components thought to exacerbate gut inflammation, can induce remission in CD patients more effectively than a control diet based on the Mediterranean pattern. Conducted as an open-label randomized trial, the research aim to provide real-world evidence of CDED's safety and its inpact on clinical remission, body composition and overall quality of life for CD patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • mild-to-moderate Crohn's disease activity (HBI between 5 and 16)

Exclusion

Exclusion Criteria:

  • concomitant treatment with corticosteroids, antibiotic therapies and nutraceuticalsupplements, treatment with biological drugs and traditional immunosuppressantsstarted less than 24 weeks before enrollment, presence of active fistulas orabscesses, gastrointestinal tract surgery less than 6 months to randomization,coeliac disease, type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus,acute coronary disease (unstable angina, myocardial infarction), advanced acute orchronic liver disease, congestive heart failure (NYHA class III-IV), acute andchronic nephropathies (GRF<30 ml/min according to the CKD-EPI formula), presence ofacute infectious diseases and pregnancy.

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: Diet
Phase:
Study Start date:
January 20, 2023
Estimated Completion Date:
August 31, 2023

Connect with a study center

  • Giorgia Bodini

    Genova, 16132
    Italy

    Site Not Available

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