Clinical trial NCT04443335: Comparison of Continuous Feeding and Sequential Feeding on Gut Microbiota and Metabolomics in Critically Ill Patients
Official title: Comparison of Continuous Feeding and Sequential Feeding on Gut Microbiota and Metabolomics in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behavior
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Shannon index
timeFrame: at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories
Secondary outcomes:
measure: bacteria bundance
timeFrame: at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories
measure: numbers of compounds
timeFrame: at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The affiliated hospital of qingdao university
state: Shan Dong Province
Study officials:
affiliation: The affiliated hospital of Qingdao
name: Bo Yao, phD
role: PRINCIPAL_INVESTIGATOR
References:
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