Project SHARE (motherS Have All the Right microbEs)

NCT ID: NCT03239197

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-05

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Microbiota

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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mother infant pair

mother infant pair, singleton infant, vaginal birth

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kimberly-Clark Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Welter, MD

Role: PRINCIPAL_INVESTIGATOR

Marshfield Clinic

Locations

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Marshfield Clinic

Marshfield, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19892944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18713063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21697884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25578246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22473366 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23111681 (View on PubMed)

Other Identifiers

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500-16-0004

Identifier Type: -

Identifier Source: org_study_id