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.
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.
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.
Adult patients (≥18 years) with active Crohn's disease treated at a single center who initiate exclusive enteral nutrition (EEN) as the sole induction therapy and are followed for 12 weeks. The study population primarily includes patients with malnutrition or nutritional risk, and many have complicated disease with intestinal fistula, stricture, and/or intra-abdominal abscess.
Cohort
Prospective
Exclusive Enteral Nutrition
Dietary supplementExclusive 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.
Clinical remission
Proportion of participants achieving clinical remission at Week 12, defined as CDAI \< 150.
Clinical response rate
Proportion of participants achieving clinical response at Week 12, defined as a decrease in Crohn's Disease Activity Index (CDAI) of at least 100 points from baseline.
Endoscopic remission rate
Proportion of participants achieving endoscopic remission at Week 12, defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) \< 4.
Endoscopic response rate
Proportion of participants achieving endoscopic response at Week 12, defined as a reduction of at least 50% in the Simple Endoscopic Score for Crohn's Disease (SES-CD) from baseline.
Mucosal healing rate
Proportion of participants achieving mucosal healing at Week 12, defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) \< 3.
Integrated microbiome, metabolomic, and transcriptomic changes during exclusive enteral nutrition treatment
Changes from baseline in microbiome composition, metabolomic profiles, and transcriptomic expression at Weeks 4, 8, and 12 during exclusive enteral nutrition treatment, assessed using stool, blood, and intestinal mucosal biopsy samples when available.
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