Effect of Standardized Nutritional Therapy on Clinical Prognosis and Cost-effectiveness of Inflammatory Bowel Disease

Effect of Standardized Nutritional Therapy on Clinical Prognosis and Cost-effectiveness of Inflammatory Bowel disease--a Prospective Study

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Other: nutrition therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • The Third Xiangya Hospital of Central South University
      • Contact: Min Liu, M.D.; Phone Number: 86-731-88618717; Email: liumin330@hotmail.com
      • Principal Investigator: Min Liu, M.D.
      • Contact: Hong Liu, M.M.; Phone Number: 86-731-88618717; Email: znxywm@163.com
      • Principal Investigator: Qin Guo, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed with inflammatory bowel disease

Exclusion Criteria:

• nothing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: inflammatory bowel disease; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: December 25, 2019
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: YYK-2019001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No