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CompletedNCT02942511Updated Apr 21, 2023

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

An observational study in Crohn's Disease and Enteral Nutrition, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
67
Ages
14 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Crohn's Disease
  • Enteral Nutrition

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 67 is below the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No exposure to Glucosteroids or immunosuppressions
  • Complete intestinal obstruction
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
67 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Changes of Best CDAI

    Time frame: 2 months

Secondary outcomes

  1. Changes of serum CRP

    Time frame: 2 months

07

Study locations

1 site
  • the Second Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310009, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02942511
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
chenyan (Yan Chen, Second Affiliated Hospital, School of Medicine, Zhejiang University) — Principal investigator
First posted
Oct 24, 2016
Start date
Jan 1, 2014
Primary completion
Jan 1, 2017
Completion
Dec 30, 2017
Last update
Apr 21, 2023
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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