About this trial
The goal of this observational study is to evaluate the effectiveness and safety of exclusive enteral nutrition (EEN) in adults with active Crohn's disease (CD), particularly in patients with complicated disease such as stricturing disease, enteric fistula, and intra-abdominal abscess. The main questions it aims to answer are:
* What is the clinical remission rate at Week 12 in adults with active CD treated with EEN? * How does EEN affect clinical response, endoscopic outcomes, inflammatory markers, nutritional status, BMI, and safety during follow-up?
Participants will:
* start EEN at baseline and be followed through Week 12; * receive EEN as the main treatment approach during the study period; * complete clinical, laboratory, nutritional, and safety assessments at prespecified follow-up visits; * undergo endoscopic assessment when endoscopy is performed as part of routine care; and * if clinically indicated, some participants with large intra-abdominal abscesses may receive percutaneous drainage and necessary antibiotic treatment.
Eligibility criteria
Qualifiers
Age ≥18 years.
Diagnosis of Crohn's disease established on the basis of overall clinical assessment, including compatible clinical history and standard endoscopic, histologic, and/or radiologic findings, as determined by the treating physician. Histologic confirmation at baseline is not required if endoscopy or biopsy is not feasible or clinically inappropriate because of severe disease, poor nutritional status, or intra-abdominal abscess/sepsis.
Active Crohn's disease at baseline, as determined by the treating physician.
Willingness to initiate and receive exclusive enteral nutrition (EEN) as the sole induction therapy as part of physician-directed routine care.
Disqualifiers
Any absolute contraindication to enteral nutrition, including but not limited to gastrointestinal perforation, uncontrolled gastrointestinal bleeding, severe hemodynamic instability/shock, or other conditions where enteral feeding is not clinically appropriate.
Immediate need for emergency surgery at baseline.
Inability or unwillingness to receive EEN as the sole induction therapy at baseline.
Any condition that, in the investigator's opinion, would make participation unsafe or would substantially interfere with study assessments or follow-up.
Trial design
Treatments tested in this trial
- Exclusive Enteral Nutrition