Crohn Disease
Conditions
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.
Interventions
OTHERDiet
Patients received Crohn's disease exclusion diet or Mediterranean diet
Sponsors
Universita degli Studi di Genova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harvey-Bradshaw Index (HBI | 12 weeks; 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Fecal calprotectin | 12 weeks; 24 weeks |
Countries
Italy
Outcome results
None listed