Adherence to Exclusive Enteral Nutrition in Patients With... | NCT04933214

Studies
Adherence to Exclusive Enteral Nutrition in Patients With Crohn's Disease

NCT04933214

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Jun 21, 2021Actual

Enrollment

131Estimated

Phase

Not provided

Conditions

Crohn Disease

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 12, 2021Actual

Primary Completion Date

Dec 12, 2021Estimated

Completion Date

Dec 12, 2021Estimated

First Submitted Date

Jun 17, 2021

First Submission Date that Met QC Criteria

Jun 17, 2021

First Posted Date

Jun 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2021

Last Update Posted Date

Jun 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

131Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence	The adherence of patients was evaluated by the ratio of daily actual intake of energy to daily target energy.	December 2020 to May 2021

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria were as follows: had diagnosed CD more than 3 months; had EEN in the past 6 months; were at least 18 years old; agreed to participate in this study.

Exclusion Criteria:

The exclusion criteria were received treatment from mental health professionals due to any mental or cognitive impairment; suffered from other serious diseases, such as heart, brain, lung, liver and kidney dysfunction; severe infection, anemia, cachexia or other serious complications were found.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

We investigated CD patients who received EEN therapy in tertiary hospital in Hangzhou from December 2020 to May 2021.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zexin Chen	Contact	15867136069		keyanlunli_zheer@163.com

Overall Officials

Name	Affiliation	Role
Yan Chen	2ndAffiliated Hospital, School of Medicine, Zhejiang University, China	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China	Recruiting	Zhejiang			China

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided