Pectin Supplemented Enteral Feedings in Critically Ill Patients

NCT ID: NCT04438473

Last Updated: 2021-07-15

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2021-12-01

Brief Summary

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The current study will enroll critically ill patients who are going to require enteral nutrition support and randomize them to standard formula enteral nutrition or pectin-supplemented enteral nutrition in 7 days. The occurrence of enteral nutrition-related complications will be recorded and compared between groups.

The study is trying to assess whether the use of pectin will improve the enteral nutrition-related complications in critically ill patients.

Detailed Description

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Conditions

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Enteral Nutrition Dietary Fiber

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pectin

sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days

Group Type EXPERIMENTAL

pectin-supplemented enteral nutrition feeding

Intervention Type DIETARY_SUPPLEMENT

sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days

Control

standard formula enteral nutrition feeding without pectin for 7 days

Group Type PLACEBO_COMPARATOR

enteral nutrition feeding

Intervention Type OTHER

standard formula enteral nutrition feeding without pectin for 7 days

Interventions

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pectin-supplemented enteral nutrition feeding

sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days

Intervention Type DIETARY_SUPPLEMENT

enteral nutrition feeding

standard formula enteral nutrition feeding without pectin for 7 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18-80 years old, with informed consent to participate;
* Critically ill patients who require enteral nutrition support

Exclusion Criteria

* Patients with lung infection at admission
* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
* Lack of enteral access
* Any condition that would contraindicate use of the enteral nutrition
* Require enteral nutrition support for less than 1week or more than 4 weeks from enrollment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pianhong Zhang, MS

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Huzhou central hospital

Huzhou, Zhejiang, China

Site Status

The first hospital of Jiaxing

Jiaxing, Zhejiang, China

Site Status

Jinhua municipal central hospital

Jinhua, Zhejiang, China

Site Status

Quzhou Kecheng People's Hospital

Quzhou, Zhejiang, China

Site Status

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Site Status

The first affiliated hospital of Wenzhou medical university

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2019-112

Identifier Type: -

Identifier Source: org_study_id

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