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NCT03239197 Clinical Trial

Project SHARE (motherS Have All the Right microbEs)

Microbiota Clinical Trial

Official title:
An Exploratory Study to Evaluate the Transfer of the Maternal Microbial Consortia to Infants During and Following Birth

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03239197
Other study ID # 500-16-0004
Secondary ID
Status Withdrawn
Phase N/A
First received August 1, 2017
Last updated December 8, 2017
Start date September 5, 2017
Est. completion date December 2018

Study information
Verified date December 2017
Source Kimberly-Clark Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2018
Est. primary completion date March 2018
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Mother- pregnant female, singleton infant

- Infant- vaginal birth, breastfeeding as primary source of nutrition

Exclusion Criteria:

- Mother- antibiotic, steroid or antimicrobial use

- Infant- antibiotic, steroid or antimicrobial use

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Marshfield Clinic Marshfield Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
Kimberly-Clark Corporation

Country where clinical trial is conducted

United States, 

References & Publications (6)

Capone 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. — View Citation

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. — View Citation

Dowd 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. — View 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. Review. — View Citation

Madan 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. Review. — View Citation

Mueller 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Maternal staphylococci is transferred to infant during and following birth. presence of maternal staphylococci strain in infant 6 weeks
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