Human Milk and Infant Intestinal Microbiome Study

December 20, 2018 updated by: Joann McDermid, University of Virginia
This study will explore the effects of skin-to-skin contact (SSC) between mothers and their babies on the infant intestinal microbiome, the maternal skin microbiome and the breast milk microbiome. This will be accomplished by administering an intervention education session to one group and a placebo education session to the second group in order to influence the magnitude of total SSC defined by the frequency and duration of contact time between the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

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
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pregnant women scheduled to deliver at the University of Virginia Health System
  • Women 18 years or older and their newborn infant
  • Stated intent to exclusively breastfeed for the duration of post-partum hospital admission
  • To have physical custody of their child when they are discharged from the hospital

Exclusion Criteria:

  • Maternal antibiotic use in the 3 months prior to delivery
  • Consumption of alcohol in the 3 months prior to delivery
  • Recreational drug use in the 3 months prior to delivery
  • Serious gastrointestinal conditions requiring medical intervention or medication during pregnancy (e.g. Crohn's disease, ulcerative colitis, celiac disease, gastrointestinal infections)
  • Serious health conditions that require medication during pregnancy

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention education
Participants will receive the intervention education and data recording package.
Other: Intervention education
An education package that includes an enhanced emphasis on maternal-infant skin-to-skin contact and a detailed activity log for recording early post-partum care practices that includes specific skin-to-skin contact time and frequency goals.
Placebo Comparator: Placebo education
Participants will receive the placebo educational and data recording package.
Other: Placebo Education
An education package that includes a basic emphasis on maternal-infant skin-to-skin contact, as well as other general post-partum care practices and a general early post-partum care practices log without specific skin-to-skin contact goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin-to-skin contact
Time Frame: Duration of hospital admission after delivery (2-3 days)
Self-reported magnitude of maternal-infant skin-to-skin contact
Duration of hospital admission after delivery (2-3 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal skin microbiome
Time Frame: Duration of hospital admission after delivery (2-3 days)
Maternal breast area skin microbiome
Duration of hospital admission after delivery (2-3 days)
Maternal breast milk microbiome
Time Frame: Duration of hospital admission after delivery (2-3 days)
Maternal first and early milk microbiome
Duration of hospital admission after delivery (2-3 days)
Infant intestinal microbiome
Time Frame: Duration of hospital admission after delivery (2-3 days)
Infant fecal microbiome
Duration of hospital admission after delivery (2-3 days)
Maternal dietary intake
Time Frame: During pregnancy
Maternal dietary intake of probiotic or culture-enhanced foods
During pregnancy

Collaborators and Investigators

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

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Joann M McDermid, MSc PhD RDN, University of Virginia

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)

July 27, 2017

Primary Completion (Actual)

December 20, 2018

Study Completion (Actual)

December 20, 2018

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • IRB# 19913

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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