Human Milk and Infant Intestinal Microbiome Study

Not Applicable

Completed

• Conditions: Breast Feeding; Human Microbiome
• Interventions: Other: Intervention education; Other: Placebo Education

• Registration Number: NCT03181269
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-08
• Study Start: 2017-07-27
• Status Verified: 2018-12
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention education	Intervention education	Participants will receive the intervention education and data recording package.
Placebo education	Placebo Education	Participants will receive the placebo educational and data recording package.

Primary Outcome Measures

Name	Time	Method
Skin-to-skin contact	Duration of hospital admission after delivery (2-3 days)	Self-reported magnitude of maternal-infant skin-to-skin contact

Secondary Outcome Measures

Name	Time	Method
Maternal skin microbiome	Duration of hospital admission after delivery (2-3 days)	Maternal breast area skin microbiome
Maternal dietary intake	During pregnancy	Maternal dietary intake of probiotic or culture-enhanced foods
Maternal breast milk microbiome	Duration of hospital admission after delivery (2-3 days)	Maternal first and early milk microbiome
Infant intestinal microbiome	Duration of hospital admission after delivery (2-3 days)	Infant fecal microbiome

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States