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

September 1, 2016 updated by: Yanhong Deng, Sun Yat-sen University

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.

Study Overview

Status

Completed

Conditions

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

Intervention / Treatment

Drug: EEN

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Guangdong
  - Guangzhou, Guangdong, China, 510000
    - The six affiliated hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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 but not fibrosis.

Exclusion Criteria:

Patients do not macth the inclusion criteria and those who refuse to taking part in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical remission after 12 weeks EEN Time Frame: July 2013 to October 2015	July 2013 to October 2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (ESTIMATE)

September 2, 2016

Study Record Updates

Last Update Posted (ESTIMATE)