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

NCT04017520 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 221

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

  • Atopy
  • Atopic Dermatitis Eczema
  • Wheezing
  • Food Allergy in Infants

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Steven Hicks, MD/PhD · Milton S. Hershey Medical Center

Eligibility

Min Age
0 Days
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2021-10-30
Completion
2028-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04017520 on ClinicalTrials.gov