Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-25 @ 8:08 PM
Study NCT ID:
NCT04443335
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2020-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Continuous Feeding and Sequential Feeding on Gut Microbiota and Metabolomics in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2020-06-21', 'studyFirstSubmitQcDate': '2020-06-21', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shannon index', 'timeFrame': 'at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories', 'description': 'Shannon index is a paramater of α diversity in gut microbiota Full-length 16S rRNA gene sequencing analysis using QIIME software'}], 'secondaryOutcomes': [{'measure': 'bacteria bundance', 'timeFrame': 'at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories', 'description': 'It is a paramater of amount of bactera by Full-length 16S rRNA gene sequencing analysis using QIIME software'}, {'measure': 'numbers of compounds', 'timeFrame': 'at the time point of 7th feeding day after achieving ≥80% of the nutrition target calories', 'description': 'it is a paramater by untargeted metabolomics analysis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Feeding Behavior']}, 'referencesModule': {'references': [{'pmid': '26773077', 'type': 'RESULT', '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.'}, {'pmid': '30348463', 'type': 'RESULT', '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.'}, {'pmid': '27974040', 'type': 'RESULT', '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.'}, {'pmid': '27602409', 'type': 'RESULT', '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.'}, {'pmid': '28938796', 'type': 'RESULT', '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.'}, {'pmid': '39798866', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n●Patients newly admitted to the ICU and fed through gastric tubes\n\nExclusion Criteria:\n\n* Patients with the ability to eat orally at admission\n* Patients with diabetes or gastrointestinal disease\n* Patients who are unable to tolerate enteral feeding\n* An estimated feeding time of less than 7 days'}, 'identificationModule': {'nctId': 'NCT04443335', 'briefTitle': 'Comparison of Continuous Feeding and Sequential Feeding on Gut Microbiota and Metabolomics in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Qingdao University'}, 'officialTitle': 'Comparison of Continuous Feeding and Sequential Feeding on Gut Microbiota and Metabolomics in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'QYFYKYLL761311920'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'continuous feeding', 'description': "The total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 24h", 'interventionNames': ['Behavioral: continous feeding']}, {'type': 'EXPERIMENTAL', 'label': 'sequential feeding', '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', 'interventionNames': ['Behavioral: sequential feeding']}], 'interventions': [{'name': 'continous feeding', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['continuous feeding']}, {'name': 'sequential feeding', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['sequential feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266000', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'The affiliated hospital of qingdao university', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'overallOfficials': [{'name': 'Bo Yao, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The affiliated hospital of Qingdao'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'connect to corresponding author by email after paper publication', 'ipdSharing': 'YES', 'description': 'connect to corresponding author by email after paper publication', 'accessCriteria': 'by appropriate reasons'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinician of critical care medicine, principal investigator', 'investigatorFullName': 'Bo Yao,phD', 'investigatorAffiliation': 'Qingdao University'}}}}