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

NCT07504510 | Recruiting

• 1 other identifier: 2024ZSLYEC-204
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Crohn's Disease

Keywords

exclusive enteral nutrition; active Crohn's disease; enteric fistula; intestinal stricture; intra-abdominal abscess

Outcome Measures

Primary Outcomes (1)

• Clinical remission

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

  Baseline to Week 12

Secondary Outcomes (13)

• Clinical response rate

  Baseline to Week 12

• Endoscopic remission rate

  Baseline to Week 12

• Endoscopic response rate

  Baseline to Week 12

• Mucosal healing rate

  Baseline to Week 12

• Fecal calprotectin normalization rate

  Baseline to Week 12

Other Outcomes (1)

• Integrated microbiome, metabolomic, and transcriptomic changes during exclusive enteral nutrition treatment

  Baseline, Week 4, Week 8, and Week 12; biopsy-based transcriptomic analyses at Baseline and Week 12 when available

Study Arms (1)

EEN Cohort

Adults (≥18 years) with active Crohn's disease receiving exclusive enteral nutrition (EEN) will be enrolled and followed for 12 weeks. The cohort will mainly include patients with complicated disease, including stricturing disease, enteric fistula, and intra-abdominal abscess. EEN regimen details, adherence, clinical outcomes, inflammatory and nutritional parameters, endoscopic outcomes when available, and safety will be assessed during follow-up.

Dietary Supplement: Exclusive Enteral Nutrition

Interventions

Exclusive Enteral Nutrition DIETARY_SUPPLEMENT

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.

EEN Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biological specimens including stool, serum, and intestinal mucosal biopsy tissues will be prospectively collected at baseline and during follow-up, as available, in participants with Crohn's disease receiving exclusive enteral nutrition (EEN). These specimens will be retained for exploratory analyses related to the mechanisms of EEN treatment, including microbiome, metabolomic, transcriptomic, and other molecular profiling studies, as applicable.

MeSH Terms

Conditions

Crohn Disease; Abdominal Abscess

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Abscess; Suppuration; Infections

Central Study Contacts

Wei Wang, MD

CONTACT

86-18702046420; wangw239@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 31, 2026
• Study Start: June 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)