Human Milk and Infant Intestinal Microbiome Study

Study Overview
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Brief Summary
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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.

Official Title
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Human Milk and Infant Intestinal Microbiome Study

Conditions
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Breast Feeding, Human Microbiome

Intervention / Treatment
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* Other: Intervention education
* Other: Placebo Education


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention education<br>Participants will receive the intervention education and data recording package. | Other: Intervention education<br>* 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.<br>|
| Placebo Comparator: Placebo education<br>Participants will receive the placebo educational and data recording package. | Other: Placebo Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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