Project SHARE (motherS Have All the Right microbEs)

December 8, 2017 updated by: Kimberly-Clark Corporation

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

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
mother infant pair
mother infant pair, singleton infant, vaginal birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal staphylococci is transferred to infant during and following birth.
Time Frame: 6 weeks
presence of maternal staphylococci strain in infant
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kimberly-Clark Corporation

Investigators

  • Principal Investigator: Joseph Welter, MD, Marshfield Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

August 1, 2017

First Submitted That Met QC Criteria

August 2, 2017

First Posted (Actual)

August 3, 2017

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 8, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 500-16-0004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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