Pectin Supplemented Enteral Feedings in Critically Ill Patients

Enteral Nutrition Clinical Trial

Official title:

The Effect of Pectin Supplement on Enteral Nutrition-related Complications in Critically Ill Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04438473
• Other study ID #: 2019-112
• Status: Withdrawn
• Phase: N/A
• Start date: July 30, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Dietary Fiber
• Enteral Nutrition

Intervention

Dietary Supplement:
• pectin-supplemented enteral nutrition feeding
sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days

Other:
• enteral nutrition feeding
standard formula enteral nutrition feeding without pectin for 7 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication of enteral feeding	Record daily diarrhea ,complications, aspiration pneumonia,poor gastric emptying	7 days
Secondary	feeding time of enteral nutrition	Record daily feeding time of enteral nutrition	7 days
Secondary	total energy intake	Record daily energy intake	7 days