NCT02942511

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

October 21, 2016

Last Update Submit

April 20, 2023

Conditions

Crohn's DiseaseEnteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • Changes of Best CDAI

    2 months

Secondary Outcomes (1)

  • Changes of serum CRP

    2 months

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • No exposure to Glucosteroids or immunosuppressions
  • Complete intestinal obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yan Chen

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 24, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2017

Study Completion

December 30, 2017

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations

CN(1)