Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease

Official title

Effectiveness and Safety of Exclusive Enteral Nutrition in Adults With Active and Complicated Crohn's Disease: A Single-Center Prospective Cohort Study

Overview

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.

Detailed description

This is a single-center, prospective observational cohort study in adults with active Crohn's disease (CD) who are treated with exclusive enteral nutrition (EEN) during the study period. The study is designed to evaluate the effectiveness and safety of EEN in adult patients with active CD, with a focus on patients with complicated disease, including stricturing disease, enteric fistula, and intra-abdominal abscess.

Eligible participants will be enrolled at the time EEN is initiated (baseline) and followed through Week 12. EEN will serve as the main treatment approach during the study period. In general, no other therapeutic medications for CD will be used. However, for some participants with large intra-abdominal abscesses, percutaneous drainage and necessary antibiotic treatment may be provided when clinically indicated. EEN-related management, including formula type, administration route, caloric targets, and duration, will be recorded.

The primary observation time point is Week 12. The primary endpoint is the clinical remission rate at Week 12. Secondary endpoints include the clinical response rate, endoscopic remission rate, endoscopic response rate, mucosal healing rate, proportion of participants achieving normalization of inflammatory markers, and improvement in body mass index (BMI). Endoscopic outcomes will be assessed when endoscopy is performed as part of routine care. Clinical, laboratory, nutritional, and safety assessments will be collected at prespecified follow-up visits.

Exploratory endpoints include longitudinal changes in the gut microbiome, metabolomic profiles, transcriptomic features, and candidate molecular biomarkers, as well as their associations with clinical and nutritional improvement after EEN treatment.

Interventions

• Dietary supplement 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 com

Primary outcome measures

• Clinical remission [Time frame: Baseline to Week 12]

Secondary outcome measures (12)

• Clinical response rate [Time frame: Baseline to Week 12]
• Endoscopic remission rate [Time frame: Baseline to Week 12]
• Endoscopic response rate [Time frame: Baseline to Week 12]
• Mucosal healing rate [Time frame: Baseline to Week 12]
• Fecal calprotectin normalization rate [Time frame: Baseline to Week 12]
• CRP normalization rate [Time frame: Baseline to Week 12]
• Improvement in body mass index [Time frame: Baseline to Week 12]
• Bowel ultrasound response rate [Time frame: Baseline to Week 12]
• Radiologic response rate on cross-sectional imaging [Time frame: Baseline to Week 12]
• Radiologic remission rate on cross-sectional imaging [Time frame: Baseline to Week 12]
• Stricture-related imaging response rate [Time frame: Baseline to Week 12]
• Complete stricture resolution rate on cross-sectional imaging [Time frame: Baseline to Week 12]

Eligibility criteria

Inclusion criteria

• 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.
• Presence of malnutrition or nutritional risk and clinical indication for EEN.
• Patients with intestinal complications, including enteric fistula, intestinal stricture, and/or intra-abdominal abscess, are eligible if considered appropriate for EEN-based management by the treating physician.
• Ability and willingness to provide written informed consent and to comply with study assessments and follow-up for 12 weeks.

Optional clarifying note:

In participants without histologic confirmation at baseline, the diagnosis may be further confirmed during follow-up when clinically feasible, including by endoscopic biopsy or surgical pathology.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07504510 · 2020ZSLYEC-112

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗