Comparing two dietary approaches for managing Crohn's disease
The Crohn's Disease Exclusion Diet With Early Dairy Introduction vs Partial Enteral Nutrition (CD-EDEN) in Adult Patients With Crohn's Disease
This study is testing whether a special diet with or without dairy can help adults with Crohn's disease feel better and stay in remission.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Evangelismos Hospital Academic / other |
| Locations | 1 site (Athens, Attica) |
| Trial ID | NCT05606419 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Crohn's Disease Exclusion Diet (CDED) combined with either partial enteral nutrition (PEN) or early introduction of dairy products in adult patients with Crohn's disease. The aim is to determine which dietary approach better helps manage the condition and maintain remission. Participants will be monitored for clinical activity and inflammation levels throughout the study. The research seeks to address the challenges of dietary compliance and the impact of diet on disease management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with clinically active Crohn's disease.
Not a fit: Patients under 18 years old or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective dietary management strategy for patients with Crohn's disease, potentially improving their quality of life.
How similar studies have performed: While dietary interventions have been explored in Crohn's disease, this specific comparison of CDED with dairy introduction versus PEN is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have an established diagnosis of CD * Participants must have clinically active disease defined as HBI ≥ 5 * Participants must have confirmed inflammation at screening as CRP \> 5 mg/L, FC \>100 mg/g, or presence of inflammation on endoscopy in the 3 months before screening based on retrospective review of procedure reports by the local investigator and the clinician's assessment * Individuals able to give informed consent and willingness to participate Exclusion Criteria: * Age \< 18 years old * Previous extensive bowel resection * Reported pregnancy or lactation * Current stoma * Current abscess * Clinically significant stricture * Introduction of or change in dose of drug therapy within the past 8 weeks * Comorbidities including diabetes or coeliac disease, or other concomitant serious comorbidity e.g. significant psychiatric, hepatic, renal, endocrine, respiratory, neurological, cardiovascular, neoplastic or other autoimmune disease * Food allergies or intolerances, which do not permit participation in the study * Any proven current infection such as positive stool cultures or positive tests for parasites or C. difficile. Stool tests are mandatory only if diarrhea is present.
Where this trial is running
Athens, Attica
- Evangelismos General Hospital of Athens — Athens, Attica, Greece (Recruiting)
Study contacts
- Principal investigator: Dimitrios Karayiannis, Dr. — Evangelismos General Hospital of Athens
- Study coordinator: Konstantina Morogianni, MSc
- Email: konstantina.morogianni@gmail.com
- Phone: +30 2132045035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.