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出境医 / 临床实验 / Adherence to Exclusive Enteral Nutrition in Patients With Crohn's Disease

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

Study Description
Brief Summary:
The study has not yet been completed

Condition or disease
Crohn Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 131 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Adherence to Exclusive Enteral Nutrition in Patients With Crohn's Disease
Actual Study Start Date : May 12, 2021
Estimated Primary Completion Date : December 12, 2021
Estimated Study Completion Date : December 12, 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Adherence [ Time Frame: December 2020 to May 2021 ]
    The adherence of patients was evaluated by the ratio of daily actual intake of energy to daily target energy.


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We investigated CD patients who received EEN therapy in tertiary hospital in Hangzhou from December 2020 to May 2021.
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.
Contacts and Locations

Contacts
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Contact: Zexin Chen 15867136069 keyanlunli_zheer@163.com

Locations
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China
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China Recruiting
Zhejiang, China
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Director: Yan Chen 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
Tracking Information
First Submitted Date June 17, 2021
First Posted Date June 21, 2021
Last Update Posted Date June 21, 2021
Actual Study Start Date May 12, 2021
Estimated Primary Completion Date December 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 17, 2021) 		Adherence [ Time Frame: December 2020 to May 2021 ]
The adherence of patients was evaluated by the ratio of daily actual intake of energy to daily target energy.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Adherence to Exclusive Enteral Nutrition in Patients With Crohn's Disease
Official Title Adherence to Exclusive Enteral Nutrition in Patients With Crohn's Disease
Brief Summary The study has not yet been completed
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population We investigated CD patients who received EEN therapy in tertiary hospital in Hangzhou from December 2020 to May 2021.
Condition Crohn Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 17, 2021) 		131
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 12, 2021
Estimated Primary Completion Date December 12, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Zexin Chen 15867136069 keyanlunli_zheer@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04933214
Other Study ID Numbers 2021-0324
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators Not Provided
Investigators
Study Director: Yan Chen 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date May 2021