Human Milk and Infant Intestinal Microbiome Study

Completed · Not applicable · Has a placebo group

Conditions studied: Breast Feeding, Human Microbiome

In brief

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.

Key facts

Study ID

NCT03181269

Run by

University of Virginia

People needed

6

Starts

2017-07-27

Expected to finish

2018-12-20

Last updated by the study team

2018-12-21

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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