Actively Recruiting
Mechanistic Effects of Early Life Feeding Exposure on Infant Inflammatory and Health Status
Led by University of Idaho · Updated on 2024-07-26
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how maternal inflammation affects breastmilk composition and infant immune development in healthy full-term infants. The study focuses on examining maternal health factors such as body mass index (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) levels in breastmilk and their relationship to infant immune balance. The goal is to explore how early diet exposure, including maternal inflammation, may influence the risk of obesity and other inflammatory conditions in infants. The study is observational and will recruit 30 mother-infant pairs, including breastfeeding and formula-feeding groups matched by infant sex and maternal BMI. Breastmilk, maternal blood, infant blood, fecal, and saliva samples will be collected at multiple time points between 2 and 18 weeks postpartum. Mothers will provide surveys on diet, stress, and infant behavior, while medical records will offer additional health information. Samples will be analyzed for inflammatory markers and immune cell profiles using flow cytometry and other biomarker assays. Participants will be followed for about 12 weeks, with blood samples collected during routine pediatric visits and repeated sample collections of breastmilk and infant feces. Researchers will monitor systemic and intestinal inflammation markers in infants and correlate these with maternal inflammation and breastmilk composition. The study will measure changes in infant inflammatory profiles and explore factors affecting immune development, aiming to inform strategies that promote healthy immune function and reduce risks of obesity and inflammatory diseases.
CONDITIONS
Brief Title
Early Life Feeding Exposure and Infant Immune and Health Status.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mother is at least 18 years of age
- Mother is in third trimester (week 27 of gestation) or infant is 5 weeks old or younger
- Mother plans to feed infant breastmilk (by breastfeeding or pumping) for at least 18 weeks from delivery or plans exclusive formula feeding for at least 18 weeks
- Mother lives within 45 miles of study site or can deliver samples for visits 2, 4, and 6
- Mother is willing to attend visits 3 and 5 at the designated sample collection site
- Mother consents and complies with study protocol, except optional activities
- Mother and infant are considered healthy by the Principal Investigator
- For formula feeding group, mother-infant pair can be matched to breastfeeding pair by maternal BMI and infant sex
You will not qualify if you...
- Mother or infant has participated or is currently participating in interventional drug or device research
- Mother or infant had adverse effects during previous venous blood collection
- Infant was born before 36 weeks of gestation
- Infant or mother has health conditions that increase risk of study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 weeks (from third trimester to 5 weeks postpartum)
Participants are screened for eligibility to participate in the trial.
1 to 2 visits depending on eligibility confirmation
Duration - 12 weeks
Participants are observed to collect biological samples and survey data to assess infant and maternal inflammatory and immune status.
Multiple sample collections including infant blood at 2 and 4 months, infant fecal samples at 5 timepoints between 6 to 18 weeks, breastmilk samples at 5 timepoints, maternal blood at 2 and 4 months postpartum, and recurring maternal surveys
Trial Site Locations
Total: 1 location
1
University of Idaho
Moscow, Idaho, United States, 83844
Actively Recruiting
Research Team
B
Bethaney Fehrenkamp, PhD
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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