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

University of Genoa (UniGe)

Status

Completed

Conditions

Crohn Disease

Treatments

Other: Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06448819

CDED-1

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

concomitant treatment with corticosteroids, antibiotic therapies and nutraceutical supplements, treatment with biological drugs and traditional immunosuppressants started less than 24 weeks before enrollment, presence of active fistulas or abscesses, 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 or chronic liver disease, congestive heart failure (NYHA class III-IV), acute and chronic nephropathies (GRF<30 ml/min according to the CKD-EPI formula), presence of acute infectious diseases and pregnancy.