Human Milk and Infant Intestinal Microbiome Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Virginia
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Skin-to-skin contact
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intervention education
Participants will receive the intervention education and data recording package.
Intervention: Intervention education (Other)
Placebo education
Participants will receive the placebo educational and data recording package.
Intervention: Placebo Education (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Maternal dietary intake(During pregnancy)
- Maternal skin microbiome(Duration of hospital admission after delivery (2-3 days))
- Maternal breast milk microbiome(Duration of hospital admission after delivery (2-3 days))
- Infant intestinal microbiome(Duration of hospital admission after delivery (2-3 days))
Investigators
Joann McDermid
Joann M. McDermid, MSc, PhD, RDN
University of Virginia