Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04835935
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-06
First Post:
2021-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microbiome, Atopic Disease, Prematurity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'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_WITH_DNA', 'description': 'Stool, breast milk, saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-04-05', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gut, oral and milk feed microbiome', 'timeFrame': 'birth to 1 year of age', 'description': 'Longitudinal stool, oral swab and milk feed samples will be analyzed for paired microbiome and metabolome patterns. The bacterial and metabolomic profiles will be correlated with the allergic sensitization patterns and diagnosis of pediatric atopic disease in participants.'}], 'primaryOutcomes': [{'measure': 'Pediatric Atopic Disease', 'timeFrame': '2-3 years of age', 'description': 'Clinical diagnosis of any atopic disease among the participants during study follow up visit. These include any food allergies, allergic rhinitis, eczema, and asthma.'}], 'secondaryOutcomes': [{'measure': 'Allergic sensitization patterns', 'timeFrame': '1-2 years', 'description': 'Allergic sensitization patterns among the participants will be measured by ImmunoCAP Multitest, which is a blood test that provides qualitative responses (positive or negative) for food and environmental allergens.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopy', 'Prematurity']}, 'referencesModule': {'references': [{'pmid': '23212289', 'type': 'BACKGROUND', 'citation': 'Raciborski F, Tomaszewska A, Komorowski J, Samel-Kowalik P, Bialoszewski AZ, Walkiewicz A, Lusawa A, Szymanski J, Opoczynska D, Druzba M, Borowicz J, Lipiec A, Kapalczynski WJ, Samolinski B. The relationship between antibiotic therapy in early childhood and the symptoms of allergy in children aged 6-8 years - the questionnaire study results. Int J Occup Med Environ Health. 2012 Sep;25(4):470-80. doi: 10.2478/S13382-012-0056-0. Epub 2012 Dec 3.'}, {'pmid': '22289356', 'type': 'BACKGROUND', 'citation': 'Silvers KM, Frampton CM, Wickens K, Pattemore PK, Ingham T, Fishwick D, Crane J, Town GI, Epton MJ; New Zealand Asthma and Allergy Cohort Study Group. Breastfeeding protects against current asthma up to 6 years of age. J Pediatr. 2012 Jun;160(6):991-6.e1. doi: 10.1016/j.jpeds.2011.11.055. Epub 2012 Jan 30.'}, {'pmid': '19052046', 'type': 'BACKGROUND', 'citation': 'Roduit C, Scholtens S, de Jongste JC, Wijga AH, Gerritsen J, Postma DS, Brunekreef B, Hoekstra MO, Aalberse R, Smit HA. Asthma at 8 years of age in children born by caesarean section. Thorax. 2009 Feb;64(2):107-13. doi: 10.1136/thx.2008.100875. Epub 2008 Dec 3.'}, {'pmid': '24492409', 'type': 'BACKGROUND', 'citation': 'Been JV, Lugtenberg MJ, Smets E, van Schayck CP, Kramer BW, Mommers M, Sheikh A. Preterm birth and childhood wheezing disorders: a systematic review and meta-analysis. PLoS Med. 2014 Jan 28;11(1):e1001596. doi: 10.1371/journal.pmed.1001596. eCollection 2014 Jan.'}, {'pmid': '24908147', 'type': 'BACKGROUND', 'citation': "Lynch SV, Wood RA, Boushey H, Bacharier LB, Bloomberg GR, Kattan M, O'Connor GT, Sandel MT, Calatroni A, Matsui E, Johnson CC, Lynn H, Visness CM, Jaffee KF, Gergen PJ, Gold DR, Wright RJ, Fujimura K, Rauch M, Busse WW, Gern JE. Effects of early-life exposure to allergens and bacteria on recurrent wheeze and atopy in urban children. J Allergy Clin Immunol. 2014 Sep;134(3):593-601.e12. doi: 10.1016/j.jaci.2014.04.018. Epub 2014 Jun 4."}, {'pmid': '26424567', 'type': 'BACKGROUND', 'citation': 'Arrieta MC, Stiemsma LT, Dimitriu PA, Thorson L, Russell S, Yurist-Doutsch S, Kuzeljevic B, Gold MJ, Britton HM, Lefebvre DL, Subbarao P, Mandhane P, Becker A, McNagny KM, Sears MR, Kollmann T; CHILD Study Investigators; Mohn WW, Turvey SE, Finlay BB. Early infancy microbial and metabolic alterations affect risk of childhood asthma. Sci Transl Med. 2015 Sep 30;7(307):307ra152. doi: 10.1126/scitranslmed.aab2271.'}, {'pmid': '23824724', 'type': 'BACKGROUND', 'citation': 'Jeurink PV, van Esch BC, Rijnierse A, Garssen J, Knippels LM. Mechanisms underlying immune effects of dietary oligosaccharides. Am J Clin Nutr. 2013 Aug;98(2):572S-7S. doi: 10.3945/ajcn.112.038596. Epub 2013 Jul 3.'}, {'pmid': '25807349', 'type': 'BACKGROUND', 'citation': 'Neu J. Preterm infant nutrition, gut bacteria, and necrotizing enterocolitis. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):285-8. doi: 10.1097/MCO.0000000000000169.'}, {'pmid': '36251466', 'type': 'DERIVED', 'citation': "Luskin K, Mortazavi D, Bai-Tong S, Bertrand K, Chambers C, Schulkers-Escalante K, Ahmad A, Luedtke S, O'Donoghue AJ, Ghassemian M, Geng B, Leibel SL, Leibel SA. Allergen Content and Protease Activity in Milk Feeds from Mothers of Preterm Infants. Breastfeed Med. 2022 Nov;17(11):947-957. doi: 10.1089/bfm.2022.0115. Epub 2022 Oct 12."}]}, 'descriptionModule': {'briefSummary': 'There is increasing recognition that the microbiome may be important in the development of allergic disease. Asthma is the most prevalent pediatric chronic disease and affects more than 300 million people worldwide. For unclear reasons, those infants born at 34 weeks and earlier are three times as likely to develop asthma. Factors such as formula feeding, C-section delivery and antibiotic exposure may play a role. Recent evidence has identified a "critical window" in early life where gut and breast milk microbial changes are most influential. The investigators propose a novel study to follow a cohort of premature babies in the NICU and after discharge home. The investigators aim to examine whether various exposures of babies in the NICU impact their milk and gut microbiome and lead to asthma and allergies.\n\nOur specific aims are:\n\n1. To assess if there is a specific pattern of gut and/or breast milk microbiome over time that is affected by the type of nutrition a baby receives (donor vs maternal vs formula) or other exposures such as antibiotics.\n2. Assess whether there are patterns in the microbiome associated with the development of allergic sensitization patterns.\n3. Determine if early patterns of the microbiome and allergic sensitization predict allergic conditions (food allergies, allergic rhinitis, eczema, asthma) by 2 years of age.\n\nThe investigators will recruit approximately 50 subjects born at 34 weeks of gestation or earlier from two local level III NICU. These subjects will be followed over their NICU course with weekly stool, milk feed, and oral saliva collection as well as documentation of relevant events including prenatal history, delivery history, nutrition and breast feeding history and antibiotic courses. Further samples will be collected after discharge at research visits that will take place Rady Children\'s Hospital until 4-6 years of age. At these visits, standardized allergy questionnaires and a blood allergy panel will be obtained. Together this data will provide a unique opportunity to identify potential shifts in the microbiome associated with nutrition, asthma and allergy in preterm infants. Ultimately, the investigators may be able to discover ways to prevent the development of asthma and allergies during this early window of opportunity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'minimumAge': '0 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premature infants born at equal or less than 34 weeks gestational age.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* premature infant equal or less than 34 weeks of age\n\nExclusion Criteria:\n\n* hypoxic ischemic encephalopathy, congenital anomaly that affects gastrointestinal system, unable to follow up'}, 'identificationModule': {'nctId': 'NCT04835935', 'acronym': 'MAP', 'briefTitle': 'Microbiome, Atopic Disease, Prematurity', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'The Association Between Milk Feedings in the Preterm Population, the Microbiome and Risk of Atopic Disease', 'orgStudyIdInfo': {'id': '181711'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'subject who developed atopic disease', 'interventionNames': ['Other: microbiome pattern']}, {'label': 'subject who did not develop atopic disease', 'interventionNames': ['Other: microbiome pattern']}], 'interventions': [{'name': 'microbiome pattern', 'type': 'OTHER', 'description': 'microbiome pattern in neonatal period', 'armGroupLabels': ['subject who developed atopic disease', 'subject who did not develop atopic disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Memorial Hospital - Rady NICU', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego - Jacobs NICU', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'de-identified microbiome and metabolome data will be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sydney Leibel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assoc Physician', 'investigatorFullName': 'Sydney Leibel', 'investigatorAffiliation': 'University of California, San Diego'}}}}