Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 6:15 PM
Study NCT ID:
NCT03340259
Status:
UNKNOWN
Last Update Posted:
2017-11-13
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intestinal Colonization in Newborn Infants With Enterostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], 'ancestors': [{'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Enterostomy effluent'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-08', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pattern of postsurgical intestinal microbiota colonization specific to each underlying condition', 'timeFrame': 'The first sample will be collected as close as possible after placement of ostomy bag. From the first collection, new samples will be collected every 3 days, until the 21st day after surgery', 'description': 'Longitudinal postsurgical microbiota colonization of the proximal remnant intestine, specific to each underlying condition'}], 'secondaryOutcomes': [{'measure': 'Associations of types of microorganism identified with below defined clinical variables', 'timeFrame': 'The aforementioned clinical variables will be collected daily and the enterostomy effluent collected from the first placement of ostomy bag and every 3 days thereafter up to 21 days after surgery', 'description': 'Associations of microbiota colonization with the mode of delivery, gestational age, postnatal age, duration of fasting, type of enteric feeding, antimicrobial therapy, H2-receptor antagonist therapy, and length of proximal remnant intestine.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Congenital malformations of the gastrointestinal tract', 'Enterostomy', 'Microbiota', 'Necrotizing enterocolitis', 'Newborn Infants', 'Spontaneous intestinal perforation'], 'conditions': ['Newborn Infants With Enterostomy by Congenital Malformations of the Gastrointestinal Tract, Necrotizing Enterocolitis and Spontaneous Intestinal Perforation']}, 'referencesModule': {'references': [{'pmid': '31767579', 'type': 'DERIVED', 'citation': 'Barreiros Mota I, Marques C, Faria A, Neto MT, Cordeiro-Ferreira G, Virella D, Pita A, Pereira-da-Silva L, Calhau C. Colonisation of the proximal intestinal remnant in newborn infants with enterostomy: a longitudinal study protocol. BMJ Open. 2019 Nov 24;9(11):e028916. doi: 10.1136/bmjopen-2019-028916.'}]}, 'descriptionModule': {'briefSummary': 'The human microbiota, a collection of microorganisms mostly settled in the gastrointestinal tract, plays a major role in the maintenance of the hosts\' health and in development of disease as well. Exposure to different conditions early in life contributes to distinct "pioneer" bacterial communities, which shape the newborn infants\' development and influence their later physiological, immunological and neurological homeostasis. Newborn infants with congenital malformations of the gastrointestinal tract (CMGIT), necrotizing enterocolitis (NEC), and spontaneous intestinal perforation (SIP) commonly require abdominal surgery and enterostomy. While intestinal microbiota has been extensively studied in infants with anatomically uninterrupted intestine, the knowledge of longitudinal intestinal colonization in this population is scarce.\n\nThis is an exploratory, observational, and longitudinal prospective study, primarily aimed to determine longitudinally the colonization of the proximal remnant intestine, in newborn infants with enterostomy after surgery (three weeks) for CMGIT, NEC and SIP. The secondary aim is to explore the associations of the colonization with the mode of delivery, gestational age, postnatal age, duration of fasting, type of enteric feeding, antimicrobial therapy, H2-receptor antagonist therapy, and length of proximal remnant intestine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newborn infants with enterostomy after surgery for CMGIT, NEC or SIP recruited at the NICU of Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisbon, Portugal.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria: newborn infants with enterostomy after surgery for CMGIT, NEC or SIP, consecutively admitted\n\nExclusion criteria: newborn infants with diagnosed inborn errors of metabolism, those whose parents or legal guardians will not consent to participate or withdrawn the consent, and those who had not complete 21 days of follow-up.'}, 'identificationModule': {'nctId': 'NCT03340259', 'briefTitle': 'Intestinal Colonization in Newborn Infants With Enterostomy', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Proximal Remnant Intestinal Colonization in Newborn Infants With Enterostomy: a Longitudinal Study', 'orgStudyIdInfo': {'id': 'MICROENTE_01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Newborn infants with enterostomy', 'description': 'Infants with enterostomy after surgery due to congenital malformations of the gastrointestinal tract, necrotizing enterocolitis, and spontaneous intestinal perforation', 'interventionNames': ['Procedure: Exposure(s) of interest: enterostomy']}], 'interventions': [{'name': 'Exposure(s) of interest: enterostomy', 'type': 'PROCEDURE', 'description': 'Newborn infants with congenital malformations of the gastrointestinal tract, necrotizing enterocolitis, and spontaneous intestinal perforation commonly require surgery and enterostomy. In these infants samples of the enterostomy effluent will be collected and DNA extracted for microbiota identification.', 'armGroupLabels': ['Newborn infants with enterostomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1169-045', 'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Luís Pereira-da-Silva, MD, PhD', 'role': 'CONTACT', 'email': 'l.pereira.silva@nms.unl.pt', 'phone': '+351 917235528'}, {'name': 'Inês B Mota, Student', 'role': 'CONTACT', 'email': 'ines.mota@nms.unl.pt', 'phone': '+351 218 803 000'}, {'name': 'Conceição Calhau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Luís Pereira-da-Silva, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maria T Neto, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gonçalo, C Ferreira, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniel Virella, MD, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ana Pita, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ana Faria, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cláudia Marques, BsC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Inês B Mota, BsC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Neonatal Intensive Care Unit, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'centralContacts': [{'name': 'Luís Pereira-da-Silva, MD, PhD', 'role': 'CONTACT', 'email': 'l.pereira.silva@nms.unl.pt', 'phone': '+351 917235528'}, {'name': 'Conceição Calhau, PhD', 'role': 'CONTACT', 'email': 'ccalhau@nms.unl.pt', 'phone': '+351 218803000'}], 'overallOfficials': [{'name': 'Luís Pereira-da-Silva, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central'}, {'name': 'Conceição Calhau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Nova de Lisboa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'CINTESIS - Center for Health Technology and Services Research, Porto', 'class': 'UNKNOWN'}, {'name': 'Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisboa', 'class': 'UNKNOWN'}, {'name': 'Universidade Nova de Lisboa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}