Pectin Supplemented Enteral Feedings in Critically Ill Patients

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Enteral Nutrition; Dietary Fiber
• Intervention / Treatment: Dietary supplement: pectin-supplemented enteral nutrition feeding; Other: enteral nutrition feeding

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital, Zhejiang University School of Medicine
    • Huzhou, Zhejiang, China, 313003
      • Huzhou Central Hospital
    • Jiaxing, Zhejiang, China, 314001
      • The First Hospital of Jiaxing
    • Jinhua, Zhejiang, China, 321000
      • Jinhua Municipal Central Hospital
    • Quzhou, Zhejiang, China, 324000
      • Quzhou Kecheng People's Hospital
    • Taizhou, Zhejiang, China, 317099
      • Taizhou Hospital of Zhejiang Province
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pectin; sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days	Dietary supplement: pectin-supplemented enteral nutrition feeding; sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days
Placebo Comparator: Control; standard formula enteral nutrition feeding without pectin for 7 days	Other: enteral nutrition feeding; standard formula enteral nutrition feeding without pectin for 7 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	7 days

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Pianhong Zhang, MS, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2019-112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No