NCT04443335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

July 2, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

June 21, 2020

Last Update Submit

November 9, 2022

Conditions

Feeding Behavior

Outcome Measures

Primary Outcomes (1)

  • Shannon index

    Shannon index is a paramater of α diversity in gut microbiota Full-length 16S rRNA gene sequencing analysis using QIIME software

    at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories

Secondary Outcomes (2)

  • bacteria bundance

    at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories

  • numbers of compounds

    at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories

Study Arms (2)

continuous feeding

SHAM COMPARATOR

The total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 24h

Behavioral: continous feeding

sequential feeding

EXPERIMENTAL

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

Behavioral: sequential feeding

Interventions

continous feedingBEHAVIORAL

At the beginning, all the patients received continuous feeding. After achieving ≥80% of the nutrition target calories (25-30 kcal/kg/d) through continuous feeding, the patients were randomly assigned into the sequential feeding (SF) group or the continuous feeding (CF) group with a random number table. Patients in the CF group received continuous feeding with constant velocity by enteral feeding pump over one day.

continuous feeding
sequential feedingBEHAVIORAL

At the beginning, all the patients received continuous feeding. After achieving ≥80% of the nutrition target calories (25-30 kcal/kg/d) through continuous feeding, the patients were randomly assigned into the sequential feeding (SF) group or the continuous feeding (CF) group with a random number table. In the SF group, continuous feeding was changed into time-restricted feeding. The total daily dosage of enteral nutrition was equally distributed during three time periods at 7-9:00, 11-13:00 and 17-19:00. Other times of the day were fasting times. Enteral nutritional suspension in each time period was administered at a uniform rate within two hours by an enteral feeding pump.

sequential feeding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The affiliated hospital of qingdao university

Qingdao, Shandong, 266000, China

Location

Related Publications (6)

  • McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available.

    PMID: 26773077RESULT

  • Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.

    PMID: 30348463RESULT

  • Lynch SV, Pedersen O. The Human Intestinal Microbiome in Health and Disease. N Engl J Med. 2016 Dec 15;375(24):2369-2379. doi: 10.1056/NEJMra1600266. No abstract available.

    PMID: 27974040RESULT

  • McDonald D, Ackermann G, Khailova L, Baird C, Heyland D, Kozar R, Lemieux M, Derenski K, King J, Vis-Kampen C, Knight R, Wischmeyer PE. Extreme Dysbiosis of the Microbiome in Critical Illness. mSphere. 2016 Aug 31;1(4):e00199-16. doi: 10.1128/mSphere.00199-16. eCollection 2016 Jul-Aug.

    PMID: 27602409RESULT

  • Kaczmarek JL, Thompson SV, Holscher HD. Complex interactions of circadian rhythms, eating behaviors, and the gastrointestinal microbiota and their potential impact on health. Nutr Rev. 2017 Sep 1;75(9):673-682. doi: 10.1093/nutrit/nux036.

    PMID: 28938796RESULT

  • Yao B, Liu JY, Liu Y, Song XX, Wang SB, Liu N, Dong ZH, Yuan ZY, Han XN, Xing JY. Sequential versus continuous feeding and its effect on the gut microbiota in critically ill patients: A randomized controlled trial. Clin Nutr ESPEN. 2025 Apr;66:245-254. doi: 10.1016/j.clnesp.2025.01.019. Epub 2025 Jan 9.

    PMID: 39798866DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Bo Yao, phD

    The affiliated hospital of Qingdao

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician of critical care medicine, principal investigator

Study Record Dates

First Submitted

June 21, 2020

First Posted

June 23, 2020

Study Start

July 2, 2020

Primary Completion

June 28, 2022

Study Completion

June 28, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

connect to corresponding author by email after paper publication

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
connect to corresponding author by email after paper publication
Access Criteria
by appropriate reasons

Locations

CN(1)