Predictors Favoring the Role of Exclusive Enteral Nutrition in Active Crohn's Disease

To idetify the factors favoring the use of enteral nutrition would be helpful to select preferred patients suitable for enteral nutrition.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Enteral Nutrition

Detailed Description

Crohn's disease (CD) is a chronic, transmural inflammatory disorder affecting the whole alimentary tract from mouth to anus. Over the past decades, the incidence of CD is either high and stable or low but rising in the worldwide. Although the precise etiopathogenesis of CD remains unknown, a number of lines of evidence showed that inappropriate diet was one of the reasons responsible for the onset of CD, and diet therapy has been gaining increasing attention in the therapeutic work-up of CD.

Due to reduced intake and high intestinal losses, over three quarters of CD patients would suffer weight loss. Involvement of small bowel in CD patients made their nutrition status much poorer than ulcerative colitis (UC) patients. Therefore, nutrition support is of great value in the management of CD. It is widely accepted that enteral nutrition could help pediatric CD patients to reach clinical and endoscopic remission, with similar efficacy but less side effects than corticosteroids. However, the value of enteral nutrition in adult active CD is still controversial, with an unstable remission rates ranging from 8% to 100%. Varied characteristics and compliance of enrolled patients might explain this wide range. Considering this, idetification of factors favoring the use of enteral nutrition would be helpful to select preferred patients suitable for enteral nutrition.

In this study, we will observe the role of enteral nutrition in active adult CD. The age, gender, serum CRP, albumin, fecal calprotectin, nutritional risk screening 2002 (NRS2002), involved intestinal segments and other items will be correlated with the changes of Crohn's disease activity index (Best CDAI) and CRP in order to idetify the factors favoring the use of enteral nutrition.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • the Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Active crohn's disease patients from the clinics and wards in the Second Affiliated Hospital, Zhejiang University

Description

Inclusion Criteria:

• Diagnosed as active CD based on clinical presentation, endoscopic and pathology results
• Has the willing to receive enteral nutrition

Exclusion Criteria:

• No exposure to Glucosteroids or immunosuppressions
• Complete intestinal obstruction

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes of Best CDAI	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes of serum CRP	2 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 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: SAHZU-GI1