Comparison of Continuous Feeding and Sequential Feeding on Gut Microbiota and Metabolomics in Critically Ill Patients

Not Applicable

Completed

• Conditions: Feeding Behavior
• Interventions: Behavioral: continous feeding; Behavioral: sequential feeding

• Registration Number: NCT04443335
• Lead Sponsor: Qingdao University

Brief Summary

Continuous feeding is the most popular enteral feeding mode in the ICU because of its lower nursing burden and theoretically better intestinal toleration. However, continuous feeding is nonphysiological. We proposed a feeding mode called sequential feeding, as it utilizes a combination of continuous feeding in the beginning, time-restricted feeding in the second stage, and oral feeding at last.

The gut microbiota plays a critical role in human health due to its many useful functions. Not only dietary structure but also eating mode (eating time for example) influenced the gut microbiota in a healthy population. Therefore, we think this new feeding mode, sequential feeding, also has different influences on gut microbiota and metabolomics in critically ill patients compared to continuous feeding.

Detailed Description

Nutrition is an important part of therapy for critically ill patients. Continuous feeding is the most popular enteral feeding mode in the ICU because of its lower nursing burden and theoretically better intestinal toleration. However, continuous feeding is nonphysiological. In our opinion, feeding mode should be changed according to gastrointestinal function and disease progression; one singe feeding mode is not always suitable for critically ill patients. We proposed a feeding mode called sequential feeding, as it utilizes a combination of continuous feeding in the beginning, time-restricted feeding in the second stage, and oral feeding at last.

The gut microbiota plays a critical role in human health due to its many useful functions, such as metabolism, vitamin metabolism, and maintenance of the intestinal barrier and immune system. Not only dietary structure but also eating mode (eating time for example) influenced the gut microbiota in a healthy population. Therefore, we think this new feeding mode, sequential feeding, also has different influences on gut microbiota and metabolomics in critically ill patients compared to continuous feeding.

Study Timeline

• Study First Submitted: 2020-06-21
• Study First Submitted QC: 2020-06-21
• Study First Posted: 2020-06-23
• Study Start: 2020-07-02
• Primary Completion: 2022-06-28
• Study Completion: 2022-06-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

●Patients newly admitted to the ICU and fed through gastric tubes

Exclusion Criteria

• Patients with the ability to eat orally at admission
• Patients with diabetes or gastrointestinal disease
• Patients who are unable to tolerate enteral feeding
• An estimated feeding time of less than 7 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous feeding	continous feeding	The total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 24h
sequential feeding	sequential feeding	This feeding mode utilizes a combination of continuous feeding in the beginning, time-restricted feeding in the second stage and oral feeding in the last stage

Primary Outcome Measures

Name	Time	Method
Shannon index	at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories	Shannon index is a paramater of α diversity in gut microbiota Full-length 16S rRNA gene sequencing analysis using QIIME software

Secondary Outcome Measures

Name	Time	Method
bacteria bundance	at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories	It is a paramater of amount of bactera by Full-length 16S rRNA gene sequencing analysis using QIIME software
numbers of compounds	at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories	it is a paramater by untargeted metabolomics analysis

Trial Locations

Locations (1)

The affiliated hospital of qingdao university; 🇨🇳 Qingdao, Shan Dong Province, China