Liquid Nutrition as Treatment for Adults With Active, Complicated Crohn's Disease
Follows adults with active Crohn's disease who use exclusive enteral nutrition for 12 weeks.
Key facts
- Who runs it
- Sixth Affiliated Hospital, Sun Yat-sen University
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease
- Status
- Recruiting
- People taking part
- 300 people, planned
- Started
- 1 Jun 2020
- Expected to end
- 31 Dec 2026
- Type of study
- Observational
- Treatments tested
- Exclusive Enteral Nutrition
- Record updated
- 4 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active Crohn's disease, including complicated disease, who are willing to take exclusive enteral nutrition (a liquid formula diet) as their only starting treatment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Active Crohn's disease. People with strictures, fistulas or abscesses in the belly can join if their doctor thinks this nutrition treatment is right for them.
- Earlier treatment
- Must be willing to use exclusive enteral nutrition as the only starting (induction) treatment. No other prior treatment is named.
Main reasons for not taking part
- Cannot be fed through the gut, for example because of a gut perforation, uncontrolled gut bleeding or severe shock
- Needs emergency surgery right away
- Cannot or does not want to use exclusive enteral nutrition as the only starting treatment
- Any condition that makes joining unsafe or gets in the way of the study visits, in the investigator's opinion
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Immediate need for emergency surgery at baseline
- Inability or unwillingness to receive EEN as the sole induction therapy at baseline
- 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
- Any condition that, in the investigator's opinion, would make participation unsafe or would substantially interfere with study assessments or follow-up
Where in China
- The Sixth Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Wang, MDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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.
The group in the trial
- 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.
Treatment: Exclusive Enteral Nutrition
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effectiveness and Safety of Exclusive Enteral Nutrition in Adults With Active and Complicated Crohn's Disease: A Single-Center Prospective Cohort Study
- Plain-language title
- Liquid Nutrition as Treatment for Adults With Active, Complicated Crohn's DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 4 August 2026