Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease
1 other identifier
observational
48
1 country
1
Brief Summary
The study aimed to prove EEN is effective for inducing early clinical remission, mucosal healing, promoting fistula closure and reducing the size of abscess to adult CD patients. They plan to include about 50 patients and observe the effect of EEN.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 29, 2016
CompletedFirst Posted
Study publicly available on registry
September 2, 2016
CompletedSeptember 2, 2016
August 1, 2016
2.3 years
August 29, 2016
September 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical remission after 12 weeks EEN
July 2013 to October 2015
Interventions
Eligibility Criteria
The detailed inclusion criteria included: 1. \>18 years old 2. Patients with CD was diagnosed clinically according to previously established international criteria \[9\] 3. The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation but not fibrosis. Intolerance or failure to steroids or IFX was judged by medical history 4. The disease was in an active period.
You may qualify if:
- \>18 years old
- Patients with CD was diagnosed clinically according to previously established international criteria \[9\]
- The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation but not fibrosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The six affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Related Publications (1)
Yang Q, Gao X, Chen H, Li M, Wu X, Zhi M, Lan P, Hu P. Efficacy of exclusive enteral nutrition in complicated Crohn's disease. Scand J Gastroenterol. 2017 Sep;52(9):995-1001. doi: 10.1080/00365521.2017.1335770. Epub 2017 Jun 9.
PMID: 28598298DERIVED
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- committee of the Sixth Affiliated Hospital of Sun Yat-sen University
Study Record Dates
First Submitted
August 29, 2016
First Posted
September 2, 2016
Study Start
July 1, 2013
Primary Completion
October 1, 2015
Last Updated
September 2, 2016
Record last verified: 2016-08