NCT04017520Active, not recruiting
Breast Milk: Influence of the Micro-transcriptome Profile on Atopy in Children Over Time
Breast Milk: Influence of the Micro-transcriptome Profile on Atopy in Children and Toddlers
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 221 (actual)
- First submitted
- 9 Jul 2019
- Start date
- 18 Jan 2018
- Primary completion date
- 30 Oct 2021
- Lead sponsor
- Milton S. Hershey Medical Center
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT04017520
What you commit to
- Study type: Observational
- Participants enrolled: 221
- From 18 Jan 2018 to the primary completion date, 30 Oct 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Maternal morbidities that could affect ability to breastfeed or influence the breast milk micro-transcriptome (eg. cancer, drug addiction, HIV).
- 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)
Other
- Plan for infant adoption, or family move \>150 km from the medical center within 12 months of delivery
- Plan to seek primary pediatric care outside the academic medical center
Who the study is looking for
- 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)
Age in the registry: 0 days to 7 days · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Milton S. Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.