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WithdrawnNCT03239197Updated Dec 12, 2017

Project SHARE (motherS Have All the Right microbEs)

An observational study in Microbiota, sponsored by Kimberly-Clark Corporation. Withdrawn at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-12-12.

Sponsored by Kimberly-Clark Corporation · Observational

Why this study was withdrawn
Sponsor request
Study type
Observational
Model
Family-based
Time perspective
Prospective
Enrollment
0
Sex
All
01

Study 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.

02

Conditions studied

  • Microbiota
03

In context

Lead sponsor

Kimberly-Clark Corporation is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

pregnant mothers and their infants, planning a vaginal birth and breastfeeding as primary source of nutrition

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Mother- pregnant female, singleton infant
  • Infant- vaginal birth, breastfeeding as primary source of nutrition

Exclusion criteria

Exclusion Criteria:

  • Mother- antibiotic, or antimicrobial use
  • Infant- antibiotic, steroid or antimicrobial use
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Family-based
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • mother infant pair

    mother infant pair, singleton infant, vaginal birth

06

What researchers measure

Primary outcomes

  1. Maternal staphylococci is transferred to infant during and following birth.

    presence of maternal staphylococci strain in infant

    Time frame: 6 weeks

07

Study locations

1 site
  • Marshfield Clinic
    Marshfield, Wisconsin 54449, United States
08

References and documents

Publications

  • 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. PubMed 19892944 ↗
  • 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. PubMed 18713063 ↗
  • 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. PubMed 21697884 ↗
  • 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. PubMed 25578246 ↗
  • 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. PubMed 22473366 ↗
  • 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. PubMed 23111681 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2017 (actual). Primary completion is estimated for Mar 2018, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2017
First posted
Aug 3, 2017
StartActual
Sep 5, 2017
Primary completionEst.
Mar 2018
CompletionEst.
Dec 2018
Last update
Dec 12, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03239197
Lead sponsor
Kimberly-Clark Corporation
Responsible party
Sponsor
First posted
Aug 3, 2017
Start date
Sep 5, 2017
Primary completion
Mar 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Dec 12, 2017

Study contacts

Joseph Welter, MD
principal investigator · Marshfield Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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