RecruitingNot Applicable

Early Life Feeding Exposure and Infant Immune and Health Status.

United States60 participantsStarted 2024-01-12

Plain-language summary

Background: Although breastfeeding has known protective effects, such as preventing childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation rate (92%) but a significant prevalence of childhood obesity (30.5% overweight/obese). Limited research exists on the impact of maternal inflammation, maternal body mass index (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) concentrations in breastmilk on infant health outcomes, especially in healthy full-term infants. Objective: This study aims to expand understanding of the role of maternal inflammation on breastmilk composition and its effect on infant immune development. The investigators seek to investigate the relationship between maternal health status, breastmilk inflammatory concentrations, and balanced immune development in infants. Additionally, the investigators aim to explore the potential influence of early diet exposure, including maternal inflammatory status, on the risk of obesity and other inflammatory conditions. Methods: Healthy full-term infants (breastfed/formula-fed) and their mothers will be recruited. Maternal inflammation markers (BMI, CRP, IL-6) and immune markers in infants will be analyzed. Flow cytometry will assess immune populations. Correlations between maternal systemic inflammation, infant inflammation, and breastmilk inflammatory markers will be examined for breastfeeding mothers. Outcomes: The investigators hypothesize breastfed infants will display a more favorable anti-inflammatory profile. This study will identify factors influencing immune development and potential pathways linking early-life exposures to long-term health outcomes. Findings will inform strategies for promoting balanced immune development and elucidate the role of early diet exposure, including maternal inflammation, as a protective or risk factor for obesity and inflammatory conditions.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion Criteria: * Mother at least 18 years of age * Mother is in third trimester (week 27 of gestation) or biological infant is 5 weeks of age or younger * Mother plans to continue to provide your infant breastmilk (by breastfeeding or by pumping) for at least 18 weeks (4.5 months) from your delivery date or mother plans to continue to provide formula exclusively to infant for at least 18 weeks of life. * Mother lives within a 45-mile radius of Study Site, or is willing to deliver samples for visits 2, 4, and 6. * Mother willing to meet at (designated sample collection site) for visits 3 and 5 for sample collection and visit activities. * Mother willing to consent and comply with all aspects of the study protocol and methods, save the optional activities and optional sample collections. * Mother and infant are considered healthy by Principle Investigator. * For Formula Fed Group: Mother-Infant dyad is able to match to a Breastfed dyad using maternal BMI and infant sex. Exclusion Criteria: * Mother or Infant have participated or are currently participating in an interventional drug or device (non-observational) research study before. * Mother reports that they, or the infant, have had an adverse effect during a venous blood collection. * Infant was born less than 36 weeks of gestation. * Infant or mother have health conditions that increase the risk of study procedures.

What they're measuring

Characterize the change in systemic inflammatory profile of healthy full-term infants

Timeframe: Through study completion, an average of 12 weeks.

Trial details

NCT IDNCT05986539

SponsorUniversity of Idaho

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-30

Contact for this trial

Bethaney Fehrenkamp, PhD

208-885-1121 bethaney@uidaho.edu