Exclusive enteral nutrition for adults with active, complicated Crohn's disease

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

This test checks whether exclusive enteral nutrition (a complete liquid diet) can induce remission and improve symptoms in adults with active or complicated Crohn's disease.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07504510 on ClinicalTrials.gov

What this trial studies

This is a single-center, prospective observational cohort in which adults with active Crohn's disease start exclusive enteral nutrition (EEN) at baseline and are followed for 12 weeks. EEN is used as the main induction therapy and details of formula, route, calories, and duration are recorded while other Crohn's medications are generally avoided. The primary endpoint is clinical remission at Week 12, with secondary endpoints including clinical response, endoscopic outcomes when performed, inflammatory marker normalization, and nutritional/BMI changes. Patients with large abscesses may receive percutaneous drainage and antibiotics when clinically indicated as part of routine care.

Who should consider this trial

Good fit: Adults (≥18 years) with active Crohn's disease who have malnutrition or nutritional risk and whose treating physician recommends EEN, including some patients with strictures, fistulas, or intra-abdominal abscesses if appropriate.

Not a fit: Patients who cannot tolerate exclusive liquid nutrition, require urgent surgery or immediate systemic therapy for uncontrolled sepsis, or have conditions that make EEN unsafe are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, EEN could induce remission, reduce inflammation, and improve nutritional status, potentially lowering the need for additional medications or surgery.

How similar studies have performed: Exclusive enteral nutrition is well established for inducing remission in pediatric Crohn's disease, but adult data—especially for complicated disease—are limited and less consistent.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Wei Wang, MD

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