Human Milk and Infant Intestinal Microbiome Study
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
6 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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