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

September 14, 2022 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
To known the effect of PHGG-rich enteral nutrition to on the infection in liver transplant recipients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PHGG
Drug: PHGG-rich enteral nutrtiion
PHGG-rich enteral nutrition
Placebo Comparator: without PHGG
Drug: PHGG-rich enteral nutrtiion
PHGG-rich enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of infections after liver transplantation
Time Frame: 30 days
the incidence of infections after 30 days of the liver transplantation
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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, 2022

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-KY-029

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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