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ACTIVE NOT RECRUITING
NCT04017520

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

Sponsor: Milton S. Hershey Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: Breast Milk: Influence of the Micro-transcriptome Profile on Atopy in Children and Toddlers

Key Details

Gender

All

Age Range

0 Days - 7 Days

Study Type

OBSERVATIONAL

Enrollment

221

Start Date

2018-01-18

Completion Date

2028-12-30

Last Updated

2026-01-28

Healthy Volunteers

Yes

Locations (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States