Human Milk and Infant Intestinal Microbiome Study

University of Virginia6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Breast Feeding Human Microbiome

Interventions

Intervention educationOTHER

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 EducationOTHER

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.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

Skin-to-skin contact

Self-reported magnitude of maternal-infant skin-to-skin contact

Time frame: Duration of hospital admission after delivery (2-3 days)

Secondary Outcomes

Maternal skin microbiome

Maternal breast area skin microbiome

Time frame: Duration of hospital admission after delivery (2-3 days)

Maternal breast milk microbiome

Maternal first and early milk microbiome

Time frame: Duration of hospital admission after delivery (2-3 days)

Infant intestinal microbiome

Infant fecal microbiome

Time frame: Duration of hospital admission after delivery (2-3 days)

Maternal dietary intake

Maternal dietary intake of probiotic or culture-enhanced foods

Time frame: During pregnancy

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.