NCT04349943

Brief Summary

To construct a standardized stepped nutritional treatment process for inpatients with inflammatory bowel disease, including nutritional risk screening and assessment, standardized nutritional treatment implementation, therapeutic effect follow-up and monitoring, family nutritional treatment follow-up, etc.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

1.1 years

First QC Date

December 25, 2019

Last Update Submit

April 14, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Improvement of nutritional status

    We collect the body composition and grip strength of every IBD patients. Body composition include the muscle and fat contents.They are all measured as kilogram. (kg). Specific nutritional guidelines will be provided based on body composition results.

    2 years

  • Improvement of quality of life

    We asked each patient to complete the quality of life scale for every IBD patient. There are 32 questions in the scale, and each question has 7 options. The higher the score, the heavier it is.We will decide whether to give psychological intervention based on the score.

    2 years

Study Arms (1)

inflammatory bowel disease

EXPERIMENTAL

According to the patient's disease condition, tube feeding time, internal and surgical diagnosis and treatment plan, standard step-based nutrition treatment was carried out for the patients with adaptive signs of nutrition treatment, and dynamic nutrition evaluation and efficacy evaluation were carried out.

Other: nutrition therapy

Interventions

With enteral nutrition as the preferred solution, the gradual transition from slow to fast, from lean to dense, from essential to whole protein type is conducted.

inflammatory bowel disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with inflammatory bowel disease

You may not qualify if:

  • nothing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third Xiangya Hospital of Central South University

Changsha, Hu'nan, 410013, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2019

First Posted

April 16, 2020

Study Start

November 26, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2021

Last Updated

April 16, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations