A: Stablishment of Prevention and Treatment System for Intestinal Dysfunction
Sponsor
Nanjing University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04507945
Collaborator
(none)
50
2
35.9
Study Details
Study Description
Brief Summary
Dysfunction and intestinal endocrine dysfunction. This project will use genomics, metabonomics, microbiome and other omics techniques to study the clinical pathway of CID integrated therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Intestinal dysfunction is defined as the damage of intestinal substance and/or function, which leads to digestion, absorption and/or mucosal barrier function.Intestinal dysfunction is defined as the damage of intestinal substance and/or function, which leads to digestion, absorption and/or mucosal barrier function.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Goal-direct Treatment of Chronic Bowel Dysfunction
Anticipated Study Start Date
:
Oct 1, 2020
Anticipated Primary Completion Date
:
Sep 30, 2021
Anticipated Study Completion Date
:
Sep 30, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: living quality
|
Drug: Nutritional Therapy, Metabolic Disorder, Regular
According to the result reported by Byrne, Wilmore, etc. in 1992 ~ 1995, the use of growth hormone, glutamine, modified diet and other measures proposed intestinal rehabilitation treatment. Then, check the patient's quality of life survey, nutritional status, inflammation indicators and other changes every three months, and use metabolomics and microbiomic tools to detect changes in the patient's nutritional metabolism, intestinal microecology, etc., and adjust the patient's nutritional treatment and microecological treatment based on the results Program.
|
| Experimental: complication
|
Drug: Nutritional Therapy, Metabolic Disorder, Regular
According to the result reported by Byrne, Wilmore, etc. in 1992 ~ 1995, the use of growth hormone, glutamine, modified diet and other measures proposed intestinal rehabilitation treatment. Then, check the patient's quality of life survey, nutritional status, inflammation indicators and other changes every three months, and use metabolomics and microbiomic tools to detect changes in the patient's nutritional metabolism, intestinal microecology, etc., and adjust the patient's nutritional treatment and microecological treatment based on the results Program.
|
Outcome Measures
Primary Outcome Measures
- nutrition index [3 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- The Patients with chronic bowel dysfunction
Exclusion Criteria:
-
Past severe underlying diseases of the respiratory system and cardiovascular system,
-
Allergy to treatment-related drugs,
-
Pregnancy,
-
Accept CID surgery.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nanjing University School of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Lei Zheng,
General surgery,
Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT04507945
Other Study ID Numbers:
- Intestinal dysfunction
First Posted:
Aug 11, 2020
Last Update Posted:
Aug 11, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: