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Stablishment of Prevention and Treatment System for Intestinal Dysfunction (A)

Primary Purpose

Bowel Dysfunction

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nutritional Therapy, Metabolic Disorder, Regular
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bowel Dysfunction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    living quality

    complication

    Arm Description

    Outcomes

    Primary Outcome Measures

    nutrition index

    Secondary Outcome Measures

    Full Information

    First Posted
    August 8, 2020
    Last Updated
    August 10, 2020
    Sponsor
    Nanjing University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04507945
    Brief Title
    Stablishment of Prevention and Treatment System for Intestinal Dysfunction
    Acronym
    A
    Official Title
    The Goal-direct Treatment of Chronic Bowel Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    September 30, 2021 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nanjing University School of Medicine

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bowel Dysfunction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    living quality
    Arm Type
    Experimental
    Arm Title
    complication
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Nutritional Therapy, Metabolic Disorder, Regular
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    nutrition index
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30172658
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30798584
    Citation
    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.
    Results Reference
    result

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    Stablishment of Prevention and Treatment System for Intestinal Dysfunction

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