Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05815355
• Other study ID #: E2016008
• Status: Completed
• Start date: July 2013
• Est. completion date: September 2015

Study information

• Verified date: April 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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. Intolerance or failure to steroids or IFX was judged by medical history

4. The disease was in an active period.

Exclusion Criteria:

1. Intolerant to EEN or need emergency surgery

2. The bowel stricture should mainly cause by fibrosis

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Dietary Supplement:
• exclusive enteral nutrition treatment group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission after 12 weeks EEN	The Crohn's disease activity index (CDAI)<150 was taken as achieving clinical remission.	July 2013 to October 2015
Primary	Mucosal healing after EEN	Mucosal healing was assessed under endoscopy with SES-CD.	July 2013 to October 2015
Secondary	The high sensitivity C-reactive protein (mg/L) -Inflammatory parameter assessment	The high sensitivity C-reactive protein (mg/L) was evaluated at baseline, week 4 and week 12.	baseline, week 4 and week 12
Secondary	Inflammatory parameter assessment	The platelet (10*9/L) was evaluated at baseline, week 4 and week 12.	baseline, week 4 and week 12
Secondary	The body mass nutritional parameter assessment	The body mass was evaluated at baseline, week 4 and week 12.	baseline, week 4 and week 12
Secondary	The albumin (g/L)- nutritional parameter assessment	The albumin (g/L) was evaluated at baseline, week 4 and week 12.	baseline, week 4 and week 12