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
About this trial
This is an interventional treatment trial for Infections
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
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
NCT ID
NCT05543226
First Posted
September 14, 2022
Last Updated
September 14, 2022
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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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