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Pectin Supplemented Enteral Feedings in Critically Ill Patients

Primary Purpose

Enteral Nutrition, Dietary Fiber

Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pectin-supplemented enteral nutrition feeding
enteral nutrition feeding
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Enteral Nutrition

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Affiliated Hospital, Zhejiang University School of Medicine
  • Huzhou central hospital
  • The first hospital of Jiaxing
  • Jinhua municipal central hospital
  • Quzhou Kecheng People's Hospital
  • Taizhou Hospital of Zhejiang Province
  • The first affiliated hospital of Wenzhou medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pectin

Control

Arm Description

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

standard formula enteral nutrition feeding without pectin for 7 days

Outcomes

Primary Outcome Measures

Complication of enteral feeding
Record daily diarrhea ,complications, aspiration pneumonia,poor gastric emptying

Secondary Outcome Measures

feeding time of enteral nutrition
Record daily feeding time of enteral nutrition
total energy intake
Record daily energy intake

Full Information

First Posted
June 17, 2020
Last Updated
July 14, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04438473
Brief Title
Pectin Supplemented Enteral Feedings in Critically Ill Patients
Official Title
The Effect of Pectin Supplement on Enteral Nutrition-related Complications in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
discontinued prematurely by sponsor for strategic reasons
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral Nutrition, Dietary Fiber

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pectin
Arm Type
Experimental
Arm Description
sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
standard formula enteral nutrition feeding without pectin for 7 days
Intervention Type
Dietary Supplement
Intervention Name(s)
pectin-supplemented enteral nutrition feeding
Intervention Description
sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days
Intervention Type
Other
Intervention Name(s)
enteral nutrition feeding
Intervention Description
standard formula enteral nutrition feeding without pectin for 7 days
Primary Outcome Measure Information:
Title
Complication of enteral feeding
Description
Record daily diarrhea ,complications, aspiration pneumonia,poor gastric emptying
Time Frame
7 days
Secondary Outcome Measure Information:
Title
feeding time of enteral nutrition
Description
Record daily feeding time of enteral nutrition
Time Frame
7 days
Title
total energy intake
Description
Record daily energy intake
Time Frame
7 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pianhong Zhang, MS
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Huzhou central hospital
City
Huzhou
State/Province
Zhejiang
ZIP/Postal Code
313003
Country
China
Facility Name
The first hospital of Jiaxing
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314001
Country
China
Facility Name
Jinhua municipal central hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China
Facility Name
Quzhou Kecheng People's Hospital
City
Quzhou
State/Province
Zhejiang
ZIP/Postal Code
324000
Country
China
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317099
Country
China
Facility Name
The first affiliated hospital of Wenzhou medical university
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China

12. IPD Sharing Statement

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Pectin Supplemented Enteral Feedings in Critically Ill Patients

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