Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-03 @ 12:00 AM
Study NCT ID:
NCT03181269
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Milk and Infant Intestinal Microbiome Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2017-06-06', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin-to-skin contact', 'timeFrame': 'Duration of hospital admission after delivery (2-3 days)', 'description': 'Self-reported magnitude of maternal-infant skin-to-skin contact'}], 'secondaryOutcomes': [{'measure': 'Maternal skin microbiome', 'timeFrame': 'Duration of hospital admission after delivery (2-3 days)', 'description': 'Maternal breast area skin microbiome'}, {'measure': 'Maternal breast milk microbiome', 'timeFrame': 'Duration of hospital admission after delivery (2-3 days)', 'description': 'Maternal first and early milk microbiome'}, {'measure': 'Infant intestinal microbiome', 'timeFrame': 'Duration of hospital admission after delivery (2-3 days)', 'description': 'Infant fecal microbiome'}, {'measure': 'Maternal dietary intake', 'timeFrame': 'During pregnancy', 'description': 'Maternal dietary intake of probiotic or culture-enhanced foods'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Feeding', 'Human Microbiome']}, 'referencesModule': {'references': [{'pmid': '28492938', 'type': 'BACKGROUND', 'citation': 'Pannaraj PS, Li F, Cerini C, Bender JM, Yang S, Rollie A, Adisetiyo H, Zabih S, Lincez PJ, Bittinger K, Bailey A, Bushman FD, Sleasman JW, Aldrovandi GM. Association Between Breast Milk Bacterial Communities and Establishment and Development of the Infant Gut Microbiome. JAMA Pediatr. 2017 Jul 1;171(7):647-654. doi: 10.1001/jamapediatrics.2017.0378.'}, {'pmid': '28094284', 'type': 'BACKGROUND', 'citation': "Murphy K, Curley D, O'Callaghan TF, O'Shea CA, Dempsey EM, O'Toole PW, Ross RP, Ryan CA, Stanton C. The Composition of Human Milk and Infant Faecal Microbiota Over the First Three Months of Life: A Pilot Study. Sci Rep. 2017 Jan 17;7:40597. doi: 10.1038/srep40597."}, {'pmid': '26955857', 'type': 'BACKGROUND', 'citation': 'Posthuma S, Korteweg FJ, van der Ploeg JM, de Boer HD, Buiter HD, van der Ham DP. Risks and benefits of the skin-to-skin cesarean section - a retrospective cohort study. J Matern Fetal Neonatal Med. 2017 Jan;30(2):159-163. doi: 10.3109/14767058.2016.1163683. Epub 2016 Mar 29.'}, {'pmid': '27885658', 'type': 'BACKGROUND', 'citation': 'Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.'}, {'pmid': '26319129', 'type': 'BACKGROUND', 'citation': "Rutten N, Van der Gugten A, Uiterwaal C, Vlieger A, Rijkers G, Van der Ent K. Maternal use of probiotics during pregnancy and effects on their offspring's health in an unselected population. Eur J Pediatr. 2016 Feb;175(2):229-35. doi: 10.1007/s00431-015-2618-1. Epub 2015 Aug 30."}, {'pmid': '24033881', 'type': 'BACKGROUND', 'citation': 'Jost T, Lacroix C, Braegger CP, Rochat F, Chassard C. Vertical mother-neonate transfer of maternal gut bacteria via breastfeeding. Environ Microbiol. 2014 Sep;16(9):2891-904. doi: 10.1111/1462-2920.12238. Epub 2013 Sep 3.'}, {'pmid': '25061514', 'type': 'BACKGROUND', 'citation': "Schloss PD, Iverson KD, Petrosino JF, Schloss SJ. The dynamics of a family's gut microbiota reveal variations on a theme. Microbiome. 2014 Jul 21;2:25. doi: 10.1186/2049-2618-2-25. eCollection 2014."}, {'pmid': '21645799', 'type': 'BACKGROUND', 'citation': 'Neu J, Rushing J. Cesarean versus vaginal delivery: long-term infant outcomes and the hygiene hypothesis. Clin Perinatol. 2011 Jun;38(2):321-31. doi: 10.1016/j.clp.2011.03.008.'}, {'pmid': '19912138', 'type': 'BACKGROUND', 'citation': 'Marin Gabriel MA, Llana Martin I, Lopez Escobar A, Fernandez Villalba E, Romero Blanco I, Touza Pol P. Randomized controlled trial of early skin-to-skin contact: effects on the mother and the newborn. Acta Paediatr. 2010 Nov;99(11):1630-4. doi: 10.1111/j.1651-2227.2009.01597.x.'}, {'pmid': '17594176', 'type': 'BACKGROUND', 'citation': 'Palmer C, Bik EM, DiGiulio DB, Relman DA, Brown PO. Development of the human infant intestinal microbiota. PLoS Biol. 2007 Jul;5(7):e177. doi: 10.1371/journal.pbio.0050177. Epub 2007 Jun 26.'}, {'pmid': '14766812', 'type': 'BACKGROUND', 'citation': 'Lindberg E, Adlerberth I, Hesselmar B, Saalman R, Strannegard IL, Aberg N, Wold AE. High rate of transfer of Staphylococcus aureus from parental skin to infant gut flora. J Clin Microbiol. 2004 Feb;42(2):530-4. doi: 10.1128/JCM.42.2.530-534.2004.'}]}, 'descriptionModule': {'briefSummary': 'This study will explore the effects of skin-to-skin contact (SSC) between mothers and their babies on the infant intestinal microbiome, the maternal skin microbiome and the breast milk microbiome. This will be accomplished by administering an intervention education session to one group and a placebo education session to the second group in order to influence the magnitude of total SSC defined by the frequency and duration of contact time between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant women scheduled to deliver at the University of Virginia Health System\n* Women 18 years or older and their newborn infant\n* Stated intent to exclusively breastfeed for the duration of post-partum hospital admission\n* To have physical custody of their child when they are discharged from the hospital\n\nExclusion Criteria:\n\n* Maternal antibiotic use in the 3 months prior to delivery\n* Consumption of alcohol in the 3 months prior to delivery\n* Recreational drug use in the 3 months prior to delivery\n* Serious gastrointestinal conditions requiring medical intervention or medication during pregnancy (e.g. Crohn's disease, ulcerative colitis, celiac disease, gastrointestinal infections)\n* Serious health conditions that require medication during pregnancy"}, 'identificationModule': {'nctId': 'NCT03181269', 'briefTitle': 'Human Milk and Infant Intestinal Microbiome Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Human Milk and Infant Intestinal Microbiome Study', 'orgStudyIdInfo': {'id': 'IRB# 19913'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention education', 'description': 'Participants will receive the intervention education and data recording package.', 'interventionNames': ['Other: Intervention education']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo education', 'description': 'Participants will receive the placebo educational and data recording package.', 'interventionNames': ['Other: Placebo Education']}], 'interventions': [{'name': 'Intervention education', 'type': 'OTHER', 'description': 'An education package that includes an enhanced emphasis on maternal-infant skin-to-skin contact and a detailed activity log for recording early post-partum care practices that includes specific skin-to-skin contact time and frequency goals.', 'armGroupLabels': ['Intervention education']}, {'name': 'Placebo Education', 'type': 'OTHER', 'description': 'An education package that includes a basic emphasis on maternal-infant skin-to-skin contact, as well as other general post-partum care practices and a general early post-partum care practices log without specific skin-to-skin contact goals.', 'armGroupLabels': ['Placebo education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Joann M McDermid, MSc PhD RDN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Joann M. McDermid, MSc, PhD, RDN', 'investigatorFullName': 'Joann McDermid', 'investigatorAffiliation': 'University of Virginia'}}}}