Comparison of Continuous Feeding and Sequential Feeding on Gut Microbiota and Metabolomics in Critically Ill Patients
Primary Purpose
Feeding Behavior
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
continous feeding
sequential feeding
Sponsored by

About this trial
This is an interventional treatment trial for Feeding Behavior
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
Sites / Locations
- The affiliated hospital of qingdao university
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
continuous feeding
sequential feeding
Arm Description
The total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 24h
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
Outcomes
Primary Outcome Measures
Shannon index
Shannon index is a paramater of α diversity in gut microbiota Full-length 16S rRNA gene sequencing analysis using QIIME software
Secondary Outcome Measures
bacteria bundance
It is a paramater of amount of bactera by Full-length 16S rRNA gene sequencing analysis using QIIME software
numbers of compounds
it is a paramater by untargeted metabolomics analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04443335
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qingdao University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
continuous feeding
Arm Type
Sham Comparator
Arm Description
The total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 24h
Arm Title
sequential feeding
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
continous feeding
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
sequential feeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Shannon index
Description
Shannon index is a paramater of α diversity in gut microbiota Full-length 16S rRNA gene sequencing analysis using QIIME software
Time Frame
at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories
Secondary Outcome Measure Information:
Title
bacteria bundance
Description
It is a paramater of amount of bactera by Full-length 16S rRNA gene sequencing analysis using QIIME software
Time Frame
at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories
Title
numbers of compounds
Description
it is a paramater by untargeted metabolomics analysis
Time Frame
at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Yao, phD
Organizational Affiliation
The affiliated hospital of Qingdao
Official's Role
Principal Investigator
Facility Information:
Facility Name
The affiliated hospital of qingdao university
City
Qingdao
State/Province
Shan Dong Province
ZIP/Postal Code
266000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
connect to corresponding author by email after paper publication
IPD Sharing Time Frame
connect to corresponding author by email after paper publication
IPD Sharing Access Criteria
by appropriate reasons
Citations:
PubMed Identifier
26773077
Citation
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. Erratum In: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200.
Results Reference
result
PubMed Identifier
30348463
Citation
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.
Results Reference
result
PubMed Identifier
27974040
Citation
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.
Results Reference
result
PubMed Identifier
27602409
Citation
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.
Results Reference
result
PubMed Identifier
28938796
Citation
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.
Results Reference
result
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Comparison of Continuous Feeding and Sequential Feeding on Gut Microbiota and Metabolomics in Critically Ill Patients
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