Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-04 @ 1:04 AM
Study NCT ID:
NCT03841994
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2019-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'gastric juice, blood, stool, breast milk, transtracheal aspirates'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2019-02-01', 'studyFirstSubmitQcDate': '2019-02-12', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment', 'timeFrame': 'within 24 hours after birth', 'description': 'Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice'}, {'measure': 'The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment', 'timeFrame': '2 weeks after birth', 'description': 'Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice'}, {'measure': 'The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment', 'timeFrame': '3~5 weeks after birth', 'description': 'Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice'}, {'measure': 'The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment', 'timeFrame': 'at 37~40 weeks of postmenstrual age', 'description': 'Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice'}], 'secondaryOutcomes': [{'measure': 'Brain MRI', 'timeFrame': 'at 37~40 weeks of postmenstrual age', 'description': 'white matter injury'}, {'measure': 'Bayley scales of infant and toddler development, third edition', 'timeFrame': 'at 18~24 months of corrected age', 'description': 'For neurodevelopmental screening, Bayley scales of infant and toddler development, third edition yields composite scores for each cognitive, language, motor.\n\nIt is considered normal when \\>85. Developmental delay is diagnosed when the mean result is below 85.\n\nNeurodevelopmental screening is considered normal when a child achieves these all.'}, {'measure': 'Incidence of major morbidity', 'timeFrame': 'at 36~40 weeks of postmenstrual age', 'description': 'Major morbidity such as bronchopulmonary dysplasia, periventricular leukomalacia, retinopathy of prematurity'}, {'measure': 'Comparison of inflammation markers', 'timeFrame': 'with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age', 'description': 'Comparison of inflammation markers such as Interleukin(IL)-1 beta/IL-1F2, IL-6, IL-8/CXCL8, Tumor necrosis factor(TNF)-alpha, etc.'}, {'measure': 'Comparison of short chain fatty acid at 4 period', 'timeFrame': 'with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age', 'description': 'Comparison of short chain fatty acid in stool and blood at 4 period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiome'], 'conditions': ['Preterm Infants']}, 'referencesModule': {'references': [{'pmid': '25635174', 'type': 'BACKGROUND', 'citation': 'Cao B, Stout MJ, Lee I, Mysorekar IU. Placental Microbiome and Its Role in Preterm Birth. Neoreviews. 2014 Dec 1;15(12):e537-e545. doi: 10.1542/neo.15-12-e537.'}, {'pmid': '26510393', 'type': 'BACKGROUND', 'citation': 'Choi Y, Kwon Y, Kim DK, Jeon J, Jang SC, Wang T, Ban M, Kim MH, Jeon SG, Kim MS, Choi CS, Jee YK, Gho YS, Ryu SH, Kim YK. Gut microbe-derived extracellular vesicles induce insulin resistance, thereby impairing glucose metabolism in skeletal muscle. Sci Rep. 2015 Oct 29;5:15878. doi: 10.1038/srep15878.'}, {'pmid': '26240939', 'type': 'BACKGROUND', 'citation': 'Cong X, Henderson WA, Graf J, McGrath JM. Early Life Experience and Gut Microbiome: The Brain-Gut-Microbiota Signaling System. Adv Neonatal Care. 2015 Oct;15(5):314-23; quiz E1-2. doi: 10.1097/ANC.0000000000000191.'}, {'pmid': '22968153', 'type': 'BACKGROUND', 'citation': 'Cryan JF, Dinan TG. Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour. Nat Rev Neurosci. 2012 Oct;13(10):701-12. doi: 10.1038/nrn3346. Epub 2012 Sep 12.'}, {'pmid': '26947798', 'type': 'BACKGROUND', 'citation': 'DiBartolomeo ME, Claud EC. The Developing Microbiome of the Preterm Infant. Clin Ther. 2016 Apr;38(4):733-9. doi: 10.1016/j.clinthera.2016.02.003. Epub 2016 Mar 2.'}, {'pmid': '28677360', 'type': 'BACKGROUND', 'citation': 'Kim MH, Rho M, Choi JP, Choi HI, Park HK, Song WJ, Min TK, Cho SH, Cho YJ, Kim YK, Yang S, Pyun BY. A Metagenomic Analysis Provides a Culture-Independent Pathogen Detection for Atopic Dermatitis. Allergy Asthma Immunol Res. 2017 Sep;9(5):453-461. doi: 10.4168/aair.2017.9.5.453.'}, {'pmid': '23990817', 'type': 'BACKGROUND', 'citation': 'Macfabe DF. Short-chain fatty acid fermentation products of the gut microbiome: implications in autism spectrum disorders. Microb Ecol Health Dis. 2012 Aug 24;23. doi: 10.3402/mehd.v23i0.19260. eCollection 2012.'}, {'pmid': '20116944', 'type': 'BACKGROUND', 'citation': 'Mshvildadze M, Neu J. The infant intestinal microbiome: friend or foe? Early Hum Dev. 2010 Jul;86 Suppl 1(Suppl 1):67-71. doi: 10.1016/j.earlhumdev.2010.01.018. Epub 2010 Feb 8.'}, {'pmid': '21448201', 'type': 'BACKGROUND', 'citation': 'Murgas Torrazza R, Neu J. The developing intestinal microbiome and its relationship to health and disease in the neonate. J Perinatol. 2011 Apr;31 Suppl 1:S29-34. doi: 10.1038/jp.2010.172.'}, {'pmid': '27981187', 'type': 'BACKGROUND', 'citation': 'Rea K, Dinan TG, Cryan JF. The microbiome: A key regulator of stress and neuroinflammation. Neurobiol Stress. 2016 Mar 4;4:23-33. doi: 10.1016/j.ynstr.2016.03.001. eCollection 2016 Oct.'}, {'pmid': '21543533', 'type': 'BACKGROUND', 'citation': 'Sanz Y. Gut microbiota and probiotics in maternal and infant health. Am J Clin Nutr. 2011 Dec;94(6 Suppl):2000S-2005S. doi: 10.3945/ajcn.110.001172. Epub 2011 May 4.'}, {'pmid': '28034304', 'type': 'BACKGROUND', 'citation': 'Stewart CJ, Embleton ND, Marrs EC, Smith DP, Nelson A, Abdulkadir B, Skeath T, Petrosino JF, Perry JD, Berrington JE, Cummings SP. Temporal bacterial and metabolic development of the preterm gut reveals specific signatures in health and disease. Microbiome. 2016 Dec 29;4(1):67. doi: 10.1186/s40168-016-0216-8.'}, {'pmid': '27051651', 'type': 'BACKGROUND', 'citation': 'Sung J, Kim N, Kim J, Jo HJ, Park JH, Nam RH, Seok YJ, Kim YR, Lee DH, Jung HC. Comparison of Gastric Microbiota Between Gastric Juice and Mucosa by Next Generation Sequencing Method. J Cancer Prev. 2016 Mar;21(1):60-5. doi: 10.15430/JCP.2016.21.1.60. Epub 2016 Mar 30.'}, {'pmid': '26846451', 'type': 'BACKGROUND', 'citation': 'Yoo JY, Rho M, You YA, Kwon EJ, Kim MH, Kym S, Jee YK, Kim YK, Kim YJ. 16S rRNA gene-based metagenomic analysis reveals differences in bacteria-derived extracellular vesicles in the urine of pregnant and non-pregnant women. Exp Mol Med. 2016 Feb 5;48(2):e208. doi: 10.1038/emm.2015.110.'}, {'pmid': '23437088', 'type': 'BACKGROUND', 'citation': 'Wang X, Buhimschi CS, Temoin S, Bhandari V, Han YW, Buhimschi IA. Comparative microbial analysis of paired amniotic fluid and cord blood from pregnancies complicated by preterm birth and early-onset neonatal sepsis. PLoS One. 2013;8(2):e56131. doi: 10.1371/journal.pone.0056131. Epub 2013 Feb 20.'}, {'pmid': '24614698', 'type': 'RESULT', 'citation': 'Ardissone AN, de la Cruz DM, Davis-Richardson AG, Rechcigl KT, Li N, Drew JC, Murgas-Torrazza R, Sharma R, Hudak ML, Triplett EW, Neu J. Meconium microbiome analysis identifies bacteria correlated with premature birth. PLoS One. 2014 Mar 10;9(3):e90784. doi: 10.1371/journal.pone.0090784. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'A prospective cohort study investigating the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.', 'detailedDescription': 'The purpose of this study was to investigate the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Preterm infants who are born at \\< 28 weeks of gestation and admitted to the neonatal intensive care unit at Seoul national university children's hospital", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants\n* born less than 28+0 weeks gestation\n\nExclusion Criteria:\n\n* Major congenital anomalies'}, 'identificationModule': {'nctId': 'NCT03841994', 'briefTitle': 'Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants', 'orgStudyIdInfo': {'id': '1801-128-917'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm infant cohort', 'description': 'Preterm infants who were born \\<28 weeks of gestational age'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ee-Kyung Kim, M.D., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ee-Kyung Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}