Stablishment of Prevention and Treatment System for Intestinal Dysfunction

NCT04507945 | Unknown Phase 1 DMC

• 1 other identifier: Intestinal dysfunction
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bowel Dysfunction

Outcome Measures

Primary Outcomes (1)

• nutrition index

  3 years

Study Arms (2)

living quality

EXPERIMENTAL

Drug: Nutritional Therapy, Metabolic Disorder, Regular

complication

EXPERIMENTAL

Drug: Nutritional Therapy, Metabolic Disorder, Regular

Interventions

Nutritional Therapy, Metabolic Disorder, Regular DRUG

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.

complication; living quality

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The Patients with chronic bowel dysfunction

You may not qualify if:

• Past severe underlying diseases of the respiratory system and cardiovascular system,
• Allergy to treatment-related drugs,
• Pregnancy,
• Accept CID surgery.

Sponsors & Collaborators

• Nanjing University School of Medicine: lead

Related Publications (2)

• 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.

  PMID: 30172658 BACKGROUND

• 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.

  PMID: 30798584 RESULT

MeSH Terms

Conditions

Intestinal Diseases

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General surgery

Model Details: Intestinal dysfunction is defined as the damage of intestinal substance and/or function, which leads to digestion, absorption and/or mucosal barrier function.

Study Record Dates

• First Submitted: August 8, 2020
• First Posted: August 11, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2023
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share