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Project SHARE (motherS Have All the Right microbEs)
An Exploratory Study to Evaluate the Transfer of the Maternal Microbial Consortia to Infants During and Following Birth
1 other identifier
observational
N/A
1 country
1
Brief Summary
This is an exploratory study designed to collect microbial samples from several body locations from 6 pairs of mothers and their newborn infants at various time points.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 3, 2017
CompletedStudy Start
First participant enrolled
September 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedDecember 12, 2017
December 1, 2017
6 months
August 1, 2017
December 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Maternal staphylococci is transferred to infant during and following birth.
presence of maternal staphylococci strain in infant
6 weeks
Study Arms (1)
mother infant pair
mother infant pair, singleton infant, vaginal birth
Eligibility Criteria
pregnant mothers and their infants, planning a vaginal birth and breastfeeding as primary source of nutrition
You may qualify if:
- Mother- pregnant female, singleton infant
- Infant- vaginal birth, breastfeeding as primary source of nutrition
You may not qualify if:
- Mother- antibiotic, steroid or antimicrobial use
- Infant- antibiotic, steroid or antimicrobial use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Related Publications (6)
Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5.
PMID: 19892944BACKGROUNDDowd SE, Sun Y, Wolcott RD, Domingo A, Carroll JA. Bacterial tag-encoded FLX amplicon pyrosequencing (bTEFAP) for microbiome studies: bacterial diversity in the ileum of newly weaned Salmonella-infected pigs. Foodborne Pathog Dis. 2008 Aug;5(4):459-72. doi: 10.1089/fpd.2008.0107.
PMID: 18713063BACKGROUNDCapone KA, Dowd SE, Stamatas GN, Nikolovski J. Diversity of the human skin microbiome early in life. J Invest Dermatol. 2011 Oct;131(10):2026-32. doi: 10.1038/jid.2011.168. Epub 2011 Jun 23.
PMID: 21697884BACKGROUNDMueller NT, Bakacs E, Combellick J, Grigoryan Z, Dominguez-Bello MG. The infant microbiome development: mom matters. Trends Mol Med. 2015 Feb;21(2):109-17. doi: 10.1016/j.molmed.2014.12.002. Epub 2014 Dec 11.
PMID: 25578246BACKGROUNDJohnson 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: 22473366BACKGROUNDMadan JC, Farzan SF, Hibberd PL, Karagas MR. Normal neonatal microbiome variation in relation to environmental factors, infection and allergy. Curr Opin Pediatr. 2012 Dec;24(6):753-9. doi: 10.1097/MOP.0b013e32835a1ac8.
PMID: 23111681BACKGROUND
Biospecimen
staphlococci isolates
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Welter, MD
Marshfield Clinic
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2017
First Posted
August 3, 2017
Study Start
September 5, 2017
Primary Completion
March 1, 2018
Study Completion
December 1, 2018
Last Updated
December 12, 2017
Record last verified: 2017-12