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Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Summary
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.
Official title: Effectiveness and Safety of Exclusive Enteral Nutrition in Adults With Active and Complicated Crohn's Disease: A Single-Center Prospective Cohort Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2024-04-01
Completion Date
2026-12-31
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Exclusive Enteral Nutrition
Exclusive enteral nutrition (EEN) consists of a nutritionally complete enteral formula used as the sole source of nutrition during the treatment period, without regular solid food intake except for water and protocol-permitted fluids. Caloric intake is individualized according to body weight, nutritional status, and clinical requirements. EEN is administered to induce disease remission and improve nutritional and inflammatory status in adults with active Crohn's disease, including those with complicated disease such as intestinal strictures or enteric fistulas.
Locations (1)
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China