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The Effect of PHGG-rich Enteral Nutrition to on the Infection in Liver Transplant Recipients: A Prospective, Double-blind, Randomized Controlled Study

Primary Purpose

Infections

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PHGG-rich enteral nutrtiion
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. liver transplant recipients
  2. age from 18 to 80 years old
  3. APACHE II score >12
  4. There is an indication for enteral nutrition and it is expected to require oral or tube feeding for more than 7 days
  5. there is no intra-abdominal infection or bloodstream infection

Exclusion Criteria:

  1. Severe cardiac, kidney and lung dysfunction
  2. bowel obstruction, intestinal perforation, intestinal leakage before operation
  3. Roux and Y anastomosis during liver transplant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    PHGG

    without PHGG

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence of infections after liver transplantation
    the incidence of infections after 30 days of the liver transplantation

    Secondary Outcome Measures

    Full Information

    First Posted
    September 14, 2022
    Last Updated
    September 14, 2022
    Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05543226
    Brief Title
    The Effect of PHGG-rich Enteral Nutrition to on the Infection in Liver Transplant Recipients: A Prospective, Double-blind, Randomized Controlled Study
    Official Title
    The Effect of PHGG-rich Enteral Nutrition to on the Infection in Liver Transplant Recipients: A Prospective, Double-blind, Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    September 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    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
    To known the effect of PHGG-rich enteral nutrition to on the infection in liver transplant recipients

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    136 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PHGG
    Arm Type
    Experimental
    Arm Title
    without PHGG
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    PHGG-rich enteral nutrtiion
    Intervention Description
    PHGG-rich enteral nutrition
    Primary Outcome Measure Information:
    Title
    Incidence of infections after liver transplantation
    Description
    the incidence of infections after 30 days of the liver transplantation
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: liver transplant recipients age from 18 to 80 years old APACHE II score >12 There is an indication for enteral nutrition and it is expected to require oral or tube feeding for more than 7 days there is no intra-abdominal infection or bloodstream infection Exclusion Criteria: Severe cardiac, kidney and lung dysfunction bowel obstruction, intestinal perforation, intestinal leakage before operation Roux and Y anastomosis during liver transplant
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qing He
    Phone
    +8613710329468
    Email
    heqing@mail.sysu.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of PHGG-rich Enteral Nutrition to on the Infection in Liver Transplant Recipients: A Prospective, Double-blind, Randomized Controlled Study

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