NCT05606419Suspended
The Crohn's Disease Exclusion Diet With Early Dairy Introduction vs Partial Enteral Nutrition for 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
Source: ClinicalTrials.gov · Last updated 30 Sept 2025
Reason given: Study was suspended on September 24 because of funding constraints. At that point, approximately 50 % of the planned participants had enrolled. All data collected to date will be analyzed.
Brief summary (registry, in English)
This study aims to evaluate a novel diet for adult Crohn's disease patients (The Crohn's Disease Exclusion Diet - CDED). Some of the patients in this study will receive the CDED combined with partial enteral nutrition (PEN), while the other group will receive the CDED with early introduction of dairy products, that were eliminated from the initial CDED protocol.
- Status (registry)
- Suspended
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 24 Oct 2022
- Start date
- 10 Mar 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Evangelismos Hospital
- Diseases
- Crohn's disease
- NCT number
- NCT05606419
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous extensive bowel resection
- 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
Other illness
- 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.
Age
- Age < 18 years old
Other
- Reported pregnancy or lactation
- Current stoma
- Current abscess
- Clinically significant stricture
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Evangelismos General Hospital of Athens | Athens | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.