Breast Milk: Influence of the Micro-transcriptome Profile on Atopy in Children Over Time

Running, not enrolling

Conditions studied: Atopy, Atopic Dermatitis Eczema, Wheezing, Food Allergy in Infants

In brief

This is an observational cohort study of 221 breast-feeding mother-infant dyads delivered at term. The goal of the study is to investigate whether levels of immune-related microRNAs (miRNAs) in maternal breast milk (MBM) influence child atopy risk in the first 12 months, defined as atopic dermatitis, wheezing, or food allergy. Infant exposure to individual miRNA components will be quantified at 0, 4, and 16-weeks after delivery using high throughput RNA sequencing of MBM samples and detailed dietary logs employing the Infant Feeding Practices (IFP) survey. The relationship of individual miRNA exposures (parts per million) and presence/absence of atopy in the 48 weeks after delivery will be assessed, while controlling for environmental exposures (National Survey of Lead hazards and Allergens in Housing), maternal diet, and genetic predisposition. Potential transfer of MBM miRNAs to the infant oropharynx and subsequent impact on immune reactivity will also be explored through RNA sequencing of infant saliva and quantification of cytokine profiles.

Key facts

Study ID

NCT04017520

Run by

Milton S. Hershey Medical Center

People needed

221

Starts

2018-01-18

Expected to finish

2028-12-30

Last updated by the study team

2026-01-28

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Mothers between the ages of 18 years adn 35 years
• Mothers plan to breast feed for minimum of 16 weeks (cessation of breastfeeding prior to this timepoint will not result in exclusion)
• Infants delivered at term (37 - 42 weeks)

You may not qualify if…

• Maternal morbidities that could affect ability to breastfeed or influence the breast milk micro-transcriptome (eg. cancer, drug addiction, HIV).
• Plan for infant adoption, or family move >150 km from the medical center within 12 months of delivery
• Presence of congenital anomaly or neonatal condition that significantly affects a newborn's ability to feed (e.g. cleft lip/palate, metabolic disease, or prolonged neonatal intensive care unit (NICU) admission >7 days)
• Plan to seek primary pediatric care outside the academic medical center

Where it is running

• Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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