Pectin Supplemented Enteral Feedings in Critically Ill Pa... | NCT04438473

Studies
Pectin Supplemented Enteral Feedings in Critically Ill Patients

NCT04438473

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Withdrawn

Last Update Posted

Jul 15, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Enteral Nutrition
Dietary Fiber

Interventions

pectin-supplemented enteral nutrition feeding
enteral nutrition feeding

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

discontinued prematurely by sponsor for strategic reasons

Expanded Access Info

Start Date

Jul 30, 2020Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Jun 17, 2020

First Submission Date that Met QC Criteria

Jun 17, 2020

First Posted Date

Jun 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2021

Last Update Posted Date

Jul 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pectin	Experimental	sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days	Dietary Supplement: pectin-supplemented enteral nutrition feeding
Control	Placebo Comparator	standard formula enteral nutrition feeding without pectin for 7 days	Other: enteral nutrition feeding

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pectin-supplemented enteral nutrition feeding	Dietary Supplement	sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days	Pectin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complication of enteral feeding	Record daily diarrhea ,complications, aspiration pneumonia,poor gastric emptying	7 days

Secondary Outcomes

Measure	Description	Time Frame
feeding time of enteral nutrition	Record daily feeding time of enteral nutrition	7 days
total energy intake	Record daily energy intake

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pianhong Zhang, MS	Second Affiliated Hospital, School of Medicine, Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital, Zhejiang University School of Medicine		Hangzhou	Zhejiang	310009	China

Intervention Browse Module

MeSH Terms

ID	Term
D004750	Enteral Nutrition

Ancestor Terms

ID	Term
D005248	Feeding Methods
D013812	Therapeutics
D018529	Nutritional Support
D044623	Nutrition Therapy

Browse Leaves

Not provided

Browse Branches

Not provided