- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04507945
Stablishment of Prevention and Treatment System for Intestinal Dysfunction (A)
August 10, 2020 updated by: Lei Zheng, Nanjing University School of Medicine
The Goal-direct Treatment of Chronic Bowel Dysfunction
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: living quality
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
nutrition index
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pironi L, Corcos O, Forbes A, Holst M, Joly F, Jonkers C, Klek S, Lal S, Blaser AR, Rollins KE, Sasdelli AS, Shaffer J, Van Gossum A, Wanten G, Zanfi C, Lobo DN; ESPEN Acute and Chronic Intestinal Failure Special Interest Groups. Intestinal failure in adults: Recommendations from the ESPEN expert groups. Clin Nutr. 2018 Dec;37(6 Pt A):1798-1809. doi: 10.1016/j.clnu.2018.07.036. Epub 2018 Aug 18.
- He D, Wang S, Hu H, Yin HY. [Advances in the research of protective effect of curcumin on intestinal mucosal barrier function]. Zhonghua Shao Shang Za Zhi. 2019 Feb 20;35(2):157-160. doi: 10.3760/cma.j.issn.1009-2587.2019.02.013. Chinese.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2020
Primary Completion (Anticipated)
September 30, 2021
Study Completion (Anticipated)
September 30, 2023
Study Registration Dates
First Submitted
August 8, 2020
First Submitted That Met QC Criteria
August 10, 2020
First Posted (Actual)
August 11, 2020
Study Record Updates
Last Update Posted (Actual)
August 11, 2020
Last Update Submitted That Met QC Criteria
August 10, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Intestinal dysfunction
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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