Clinical trial NCT03181269: Human Milk and Infant Intestinal Microbiome Study
Official title: Human Milk and Infant Intestinal Microbiome Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Human Microbiome
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Skin-to-skin contact
timeFrame: Duration of hospital admission after delivery (2-3 days)
Secondary outcomes:
measure: Maternal skin microbiome
timeFrame: Duration of hospital admission after delivery (2-3 days)
measure: Maternal breast milk microbiome
timeFrame: Duration of hospital admission after delivery (2-3 days)
measure: Infant intestinal microbiome
timeFrame: Duration of hospital admission after delivery (2-3 days)
measure: Maternal dietary intake
timeFrame: During pregnancy
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Joann M McDermid, MSc PhD RDN
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Murphy K, Curley D, O'Callaghan TF, O'Shea CA, Dempsey EM, O'Toole PW, Ross RP, Ryan CA, Stanton C. The Composition of Human Milk and Infant Faecal Microbiota Over the First Three Months of Life: A Pilot Study. Sci Rep. 2017 Jan 17;7:40597. doi: 10.1038/srep40597.
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citation: Lindberg E, Adlerberth I, Hesselmar B, Saalman R, Strannegard IL, Aberg N, Wold AE. High rate of transfer of Staphylococcus aureus from parental skin to infant gut flora. J Clin Microbiol. 2004 Feb;42(2):530-4. doi: 10.1128/JCM.42.2.530-534.2004.