NCT05543226

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

September 16, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

September 14, 2022

Last Update Submit

September 14, 2022

Conditions

Infections

Outcome Measures

Primary Outcomes (1)

  • Incidence of infections after liver transplantation

    the incidence of infections after 30 days of the liver transplantation

    30 days

Study Arms (2)

PHGG

EXPERIMENTAL
Drug: PHGG-rich enteral nutrtiion

without PHGG

PLACEBO COMPARATOR
Drug: PHGG-rich enteral nutrtiion

Interventions

PHGG-rich enteral nutrtiionDRUG

PHGG-rich enteral nutrition

PHGGwithout PHGG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infections

Central Study Contacts

Qing He

CONTACT

+8613710329468heqing@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 16, 2022

Study Start

October 1, 2022

Primary Completion

March 31, 2024

Study Completion

September 30, 2024

Last Updated

September 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share