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

Not Applicable

Completed

• Conditions: Crohn Disease
• Interventions: Other: Diet

• Registration Number: NCT06448819
• Lead Sponsor: Universita degli Studi di Genova

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-20
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDED group	Diet	Crohn's disease exclusion diet Partecipants received Crohn's disease exclusion diet or Mediterranean diet for 24 weeks

Primary Outcome Measures

Name	Time	Method
Harvey-Bradshaw Index (HBI	12 weeks; 24 weeks

Secondary Outcome Measures

Name	Time	Method
Fecal calprotectin	12 weeks; 24 weeks

Trial Locations

Locations (1)

Giorgia Bodini; 🇮🇹 Genova, Italy