Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-02 @ 10:04 AM
Study NCT ID:
NCT03235635
Status:
UNKNOWN
Last Update Posted:
2017-08-01
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metagenomic Analysis of Gut Microbiome in Preterm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015163', 'term': 'Superinfection'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009894', 'term': 'Opportunistic Infections'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'extraction microbiome DNA from stool of newborns'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-29', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-29', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intestinal microbiome', 'timeFrame': 'for 2 years', 'description': 'The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment which is one of the analysis in result of metagenomics in each infants'}], 'secondaryOutcomes': [{'measure': 'Full Enteral feeding in preterm infants', 'timeFrame': 'for 2 years', 'description': 'Days to accomplish a full-enteral feeding in each infants'}, {'measure': 'Growth rate', 'timeFrame': 'for 2 years', 'description': 'Days to reach 2 kg of body weight in each infants'}, {'measure': 'Mortality', 'timeFrame': 'for 2 years', 'description': 'Number of patients who died in neonatal intensive care unit.'}, {'measure': 'Morbidity', 'timeFrame': 'for 2 years', 'description': 'Number of patients who had a complication of preterm infants(e.g. necrotizing enterocolitis, bronchopulmonary dysplasia) or were died in neonatal intensive care unit.'}, {'measure': 'Allergic predisposition', 'timeFrame': 'for 2 years', 'description': 'Number of patients who were developed a allergic predisposition at 6 month of postnatal age.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiome', 'preterm', 'newborn', 'gut microbiome', 'allergic predisposition'], 'conditions': ['Microbial Colonization', 'Microbial Superinvasion', 'Microbial Substitution', 'Newborn Morbidity']}, 'referencesModule': {'references': [{'pmid': '28346920', 'type': 'RESULT', 'citation': 'Rautava S. Microbial Composition of the Initial Colonization of Newborns. Nestle Nutr Inst Workshop Ser. 2017;88:11-21. doi: 10.1159/000455209. Epub 2017 Mar 27.'}, {'pmid': '17460489', 'type': 'RESULT', 'citation': 'Butel MJ, Suau A, Campeotto F, Magne F, Aires J, Ferraris L, Kalach N, Leroux B, Dupont C. Conditions of bifidobacterial colonization in preterm infants: a prospective analysis. J Pediatr Gastroenterol Nutr. 2007 May;44(5):577-82. doi: 10.1097/MPG.0b013e3180406b20.'}, {'pmid': '17943116', 'type': 'RESULT', 'citation': 'Turnbaugh PJ, Ley RE, Hamady M, Fraser-Liggett CM, Knight R, Gordon JI. The human microbiome project. Nature. 2007 Oct 18;449(7164):804-10. doi: 10.1038/nature06244.'}, {'pmid': '20961563', 'type': 'RESULT', 'citation': 'Jacquot A, Neveu D, Aujoulat F, Mercier G, Marchandin H, Jumas-Bilak E, Picaud JC. Dynamics and clinical evolution of bacterial gut microflora in extremely premature patients. J Pediatr. 2011 Mar;158(3):390-6. doi: 10.1016/j.jpeds.2010.09.007. Epub 2010 Oct 18.'}, {'pmid': '22126419', 'type': 'RESULT', 'citation': 'Arboleya S, Binetti A, Salazar N, Fernandez N, Solis G, Hernandez-Barranco A, Margolles A, de Los Reyes-Gavilan CG, Gueimonde M. Establishment and development of intestinal microbiota in preterm neonates. FEMS Microbiol Ecol. 2012 Mar;79(3):763-72. doi: 10.1111/j.1574-6941.2011.01261.x. Epub 2011 Dec 15.'}, {'pmid': '22473366', 'type': 'RESULT', 'citation': 'Johnson CL, Versalovic J. The human microbiome and its potential importance to pediatrics. Pediatrics. 2012 May;129(5):950-60. doi: 10.1542/peds.2011-2736. Epub 2012 Apr 2.'}, {'pmid': '22639551', 'type': 'RESULT', 'citation': 'McElroy SJ, Weitkamp JH. Innate Immunity in the Small Intestine of the Preterm Infant. Neoreviews. 2011 Sep 1;12(9):e517-e526. doi: 10.1542/neo.12-9-e517.'}, {'pmid': '25332768', 'type': 'RESULT', 'citation': 'Groer MW, Luciano AA, Dishaw LJ, Ashmeade TL, Miller E, Gilbert JA. Development of the preterm infant gut microbiome: a research priority. Microbiome. 2014 Oct 13;2:38. doi: 10.1186/2049-2618-2-38. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'This is single center study. The investigators will try to know that relationships between intestinal microbiome and mortality in preterm infants and what relationships is between intestinal microbiome in preterm infants and morbidity, mortality.', 'detailedDescription': 'Microbiome is the collection of all the microorganisms living in association with the human body which are consist of eukaryotes, archaea, bacteria and viruses. Microbiome in an average human body number are ten times more than human cells and have about 1000 more genes than are present in the human genome. There are symbiotic relationships between human and microbiome. If investigators are able to know about relationships between newborn and intestinal microbiome, mortality and morbidity in preterm infants may be improved. The investigators will collect the first and weekly stool of participants and analyze DNA of microbiome thorough Metagenomic anlysis. The results between 3 groups(preterm, late preterm and full-term infants) will be compared. The investigators expect that a mean distribution of intestinal microbiome in newborns(preterm, late preterm and full-term) is defined and that relationships between mortality, morbidity and intestinal microbiome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'newborn infants who were born and admitted on neonatal intensive care unit of Wonju Severance Christian Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infants who were born at gestational age of less than 36 weeks from approval date to Feb 28th 2019\n* full-term infants who were born at gestational age of greater than 37 weeks from approval date to Feb 28th 2019\n\nExclusion Criteria:\n\n* newborns with congenital anomaly\n* newborns with genetic syndrome\n* newborns without consent of parents'}, 'identificationModule': {'nctId': 'NCT03235635', 'acronym': 'MAGMP', 'briefTitle': 'Metagenomic Analysis of Gut Microbiome in Preterm', 'organization': {'class': 'OTHER', 'fullName': 'Wonju Severance Christian Hospital'}, 'officialTitle': 'Metagenome Analysis of Intestinal Microbiome in Mortality and Morbidity of Preterm Infants', 'orgStudyIdInfo': {'id': 'microbiome in nicu'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm', 'description': 'newborn infants were born with a gestational age of less than 32 weeks'}, {'label': 'Late preterm', 'description': 'newborn infants were born with a gestational age of greater than 32 weeks and less than 36 weeks'}, {'label': 'full-term', 'description': 'newborn infants were born with a gestational age of greater than or equal to 37 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '26426', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Byoungkook Lee', 'role': 'CONTACT', 'email': 'raphael3067@gmail.com', 'phone': '+82-10-6301-3067'}], 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'centralContacts': [{'name': 'Byoungkook Lee', 'role': 'CONTACT', 'email': 'raphael3067@gmail.com', 'phone': '+82-10-6301-3067'}], 'overallOfficials': [{'name': 'Byoungkook Lee', 'role': 'STUDY_CHAIR', 'affiliation': 'Wonju Severance Christian Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'starting from august 2017 until February 2019', 'ipdSharing': 'YES', 'description': 'Yes: There is a plan to make IPD and related data dictionaries available.', 'accessCriteria': 'neonatology pediatrics infections'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wonju Severance Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Byoungkook Lee', 'investigatorAffiliation': 'Wonju Severance Christian Hospital'}}}}