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Completed

NCT Number: NCT03181269

Human Milk and Infant Intestinal Microbiome Study

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.

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Key information

Conditions

Breast Feeding Behavior Feeding Behavior Human Microbiome

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention education

Other

An education package that includes an enhanced emphasis on maternal-infant skin-to-skin contact and a detailed activity log for recording early post-partum care practices that includes specific skin-to-skin contact time and frequency goals.

Placebo Education

Other

An education package that includes a basic emphasis on maternal-infant skin-to-skin contact, as well as other general post-partum care practices and a general early post-partum care practices log without specific skin-to-skin contact goals.

Primary outcomes

  1. 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

  1. Maternal skin microbiome

    Time frame: Duration of hospital admission after delivery (2-3 days)

    Maternal breast area skin microbiome

  2. Maternal breast milk microbiome

    Time frame: Duration of hospital admission after delivery (2-3 days)

    Maternal first and early milk microbiome

  3. Infant intestinal microbiome

    Time frame: Duration of hospital admission after delivery (2-3 days)

    Infant fecal microbiome

  4. Maternal dietary intake

    Time frame: During pregnancy

    Maternal dietary intake of probiotic or culture-enhanced foods

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 8, 2017
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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