NCT Number: NCT05815355
Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease
Patients with Crohn's disease (CD) could develop complications such as stricture, intestinal fistula and abdominal abscess. Some CD patients had poor response to medical therapy. The efficacy of exclusive enteral nutrition (EEN) to these adult active CD patients is still unclear. The investigators aim to study the efficacy of EEN in induction of remission in adult active CD patients with complications or poor response to drugs.
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Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Observational
About this study
Active CD patients following up in our center who had been diagnosed as complicated disease with stricture, intestinal fistula, abdominal abscess and no response to drugs, were recruited since July 2013. Patients were only offered EEN for 12 weeks without using other drugs except that patients with abscess could use antibiotic therapy with or without percutaneous drainage. The disease activity was assessed by the Crohn's disease activity index (CDAI). CDAI<150 was taken as achieving clinical remission. Demographics and clinical variables were recorded. Nutritional (body mass index, albumin) and inflammatory (High sensitivity C-reactive protein and platelet) index were evaluated at baseline, week 4 and week 12. Some patients performed colonoscopy and/or computed tomography enterography (CTE) /resonance enterography(MRE) before and after EEN. Mucosal healing was assessed under endoscopy with SES-CD and the size of abscess was detected by CTE /MRE.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- >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. Intolerance or failure to steroids or IFX was judged by medical history
- The disease was in an active period.
Exclusion criteria
- Intolerant to EEN or need emergency surgery
- The bowel stricture should mainly cause by fibrosis
Treatment and study plan
Primary outcomes
-
Clinical remission after 12 weeks EEN
Time frame: July 2013 to October 2015
The Crohn's disease activity index (CDAI)<150 was taken as achieving clinical remission.
-
Mucosal healing after EEN
Time frame: July 2013 to October 2015
Mucosal healing was assessed under endoscopy with SES-CD.
Secondary outcomes
-
The high sensitivity C-reactive protein (mg/L) -Inflammatory parameter assessment
Time frame: baseline, week 4 and week 12
The high sensitivity C-reactive protein (mg/L) was evaluated at baseline, week 4 and week 12.
-
Inflammatory parameter assessment
Time frame: baseline, week 4 and week 12
The platelet (10*9/L) was evaluated at baseline, week 4 and week 12.
-
The body mass nutritional parameter assessment
Time frame: baseline, week 4 and week 12
The body mass was evaluated at baseline, week 4 and week 12.
-
The albumin (g/L)- nutritional parameter assessment
Time frame: baseline, week 4 and week 12
The albumin (g/L) was evaluated at baseline, week 4 and week 12.
Sponsors and collaborators
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Other
Registry information
Official study title
Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Apr 18, 2023
- Registry last updated
- Apr 18, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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