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

NCT07504510 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-05-19

No results posted yet for this 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.

Conditions

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 complicated disease such as intestinal strictures or enteric fistulas.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07504510 on ClinicalTrials.gov