Actively Recruiting
Early Life Feeding Exposure and Infant Immune and Health Status.
Led by University of Idaho · Updated on 2024-07-26
60
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Life Feeding Exposure and Infant Immune and Health Status.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 provide breastmilk (breastfeeding or pumping) for at least 18 weeks from delivery or plans to provide formula exclusively for at least 18 weeks of infant's life
- Mother lives within 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
- Mother willing to consent and comply with all study procedures except optional activities
- Mother and infant considered healthy by Principal Investigator
- For formula-fed group: mother-infant pair can be matched to a breastfed pair by maternal BMI and infant sex
You will not qualify if you...
- Mother or infant previously or currently participated in interventional drug or device research
- Mother reports adverse effect to venous blood collection for self or infant
- Infant born before 36 weeks gestation
- Infant or mother have health conditions increasing risk of study procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Idaho
Moscow, Idaho, United States, 83844
Actively Recruiting
Research Team
B
Bethaney Fehrenkamp, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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