Effect of Standardized Nutritional Therapy on Clinical Prognosis and Cost-effectiveness of Inflammatory Bowel Disease
Primary Purpose
Inflammatory Bowel Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nutrition therapy
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with inflammatory bowel disease
Exclusion Criteria:
- nothing
Sites / Locations
- the Third Xiangya Hospital of Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
inflammatory bowel disease
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04349943
First Posted
December 25, 2019
Last Updated
April 14, 2020
Sponsor
The Third Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04349943
Brief Title
Effect of Standardized Nutritional Therapy on Clinical Prognosis and Cost-effectiveness of Inflammatory Bowel Disease
Official Title
Effect of Standardized Nutritional Therapy on Clinical Prognosis and Cost-effectiveness of Inflammatory Bowel disease--a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Third Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Nutrition therapy of inflammatory bowel disease should follow the principle of sequential treatment of nutrition, which is the preferred scheme with enteral nutrition, from slow to fast, from weak to strong, from the elements to the whole protein on the steps of the gradual transition, in order to improve enteral nutrition in patients with tolerance and compliance and improve patient quality of life and long-term survival rate, reduce the social burden of disease, patients with good economic and social benefits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
inflammatory bowel disease
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
nutrition therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of nutritional status
Description
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.
Time Frame
2 years
Title
Improvement of quality of life
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with inflammatory bowel disease
Exclusion Criteria:
nothing
Facility Information:
Facility Name
the Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Liu, M.D.
Phone
86-731-88618717
Email
liumin330@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hong Liu, M.M.
Phone
86-731-88618717
Email
znxywm@163.com
First Name & Middle Initial & Last Name & Degree
Min Liu, M.D.
First Name & Middle Initial & Last Name & Degree
Qin Guo, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Standardized Nutritional Therapy on Clinical Prognosis and Cost-effectiveness of Inflammatory Bowel Disease
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