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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Dietary supplement: exclusive enteral nutrition treatment group

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 48

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All consecutive adult active CD patients followed up in our center and had been diagnosed with disease complications including stricture, intestinal fistula, abdominal abscess or no response to drugs. Patients were recruited from July 2013 to July 2015.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mucosal healing after EEN	Mucosal healing was assessed under endoscopy with SES-CD.	July 2013 to October 2015

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Inflammatory parameter assessment	The platelet (10*9/L) was evaluated at baseline, week 4 and week 12.	baseline, week 4 and week 12
The body mass nutritional parameter assessment	The body mass was evaluated at baseline, week 4 and week 12.	baseline, week 4 and week 12
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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 25, 2022
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: E2016008