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

NCT ID: NCT05543226

Last Updated: 2022-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-09-30

Brief Summary

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

Detailed Description

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Conditions

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Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PHGG

Group Type EXPERIMENTAL

PHGG-rich enteral nutrtiion

Intervention Type DRUG

PHGG-rich enteral nutrition

without PHGG

Group Type PLACEBO_COMPARATOR

PHGG-rich enteral nutrtiion

Intervention Type DRUG

PHGG-rich enteral nutrition

Interventions

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PHGG-rich enteral nutrtiion

PHGG-rich enteral nutrition

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Qing He

Role: CONTACT

+8613710329468

Other Identifiers

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2022-KY-029

Identifier Type: -

Identifier Source: org_study_id

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