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

NCT07504510 · tracked via the Priya Life Science China tracker

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Phase

Observational

Started

2020-06-01

Last updated

2026-08-04

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

Exclusive Enteral Nutrition

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age ≥18 years. 2. 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. 3. Active Crohn's disease at baseline, as determined by the treating physician. 4. Willingness to initiate and receive exclusive enteral nutrition (EEN) as the sole induction therapy as part of physician-directed routine care. 5. Presence of malnutrition or nutritional risk and clinical indication for EEN. 6. 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. 7. 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 1. 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. 2. Immediate need for emergency surgery at baseline. 3. Inability or unwillingness to receive EEN as the sole induction therapy at baseline. 4. Any condition that, in the investigator's opinion, would make participation unsafe or would substantially interfere with study assessments or follow-up.

Primary outcome measure(s)

Clinical remission — Baseline to Week 12
Proportion of participants achieving clinical remission at Week 12, defined as CDAI \< 150.

Trial sites (1)

Facility	City	Region	Status
The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07504510 on ClinicalTrials.gov ↗ ← All trials in China