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

Crohn Disease Clinical Trial

Official title:

Real-life Use of the Crohn's Disease Exclusion Diet (CDED) in Adult Patients With Mild-to-moderate Crohn's Disease Activity: an Open Label, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06448819
• Other study ID #: CDED-1
• Status: Completed
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: June 2024
• Source: Universita degli Studi di Genova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• Diet
Patients received Crohn's disease exclusion diet or Mediterranean diet

Locations

Country	Name	City	State
Italy	Giorgia Bodini	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Universita degli Studi di Genova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harvey-Bradshaw Index (HBI		12 weeks; 24 weeks
Secondary	Fecal calprotectin		12 weeks; 24 weeks