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

NCT06448819 | Completed

• 1 other identifier: CDED-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Harvey-Bradshaw Index (HBI

  12 weeks; 24 weeks

Secondary Outcomes (1)

• Fecal calprotectin

  12 weeks; 24 weeks

Study Arms (2)

CDED group

EXPERIMENTAL

Crohn's disease exclusion diet Partecipants received Crohn's disease exclusion diet or Mediterranean diet for 24 weeks

Other: Diet

Mediterranean group

NO INTERVENTION

Interventions

Diet OTHER

Patients received Crohn's disease exclusion diet or Mediterranean diet

CDED group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita degli Studi di Genova: lead

Study Sites (1)

Giorgia Bodini

Genova, 16132, Italy

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Diet

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: January 20, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)