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Breast Milk's hidden clues: could MicroRNAs predict baby allergies?

NCT ID NCT04017520

Knowledge-focused Sponsor: Milton S. Hershey Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 221 breastfeeding mothers and their babies to see if small molecules called microRNAs in breast milk are linked to allergies, eczema, or wheezing in the first year of life. Researchers measured these molecules in milk samples and tracked babies' health. The goal is to understand how breast milk may influence a child's immune system, but this study does not test any treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

221 people

The number who actually took part.

Started

Jan 2018

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will be divided post-hoc into two groups based on the presence or absence of infant atopy in the first 12 months after birth (as defined by development of AD, wheezing, or food allergy, by American Academy of Allergy, Asthma, and Immunology guidelines). Given published rates of infant atopy \~30% of infants will experience atopy in the first 12 months. Thus, the projected enrollment of 221 mother-infant dyads should yield 66 atopic infants and 134 non-atopic infants. Drop outs will be replaced. The investigators expect to enroll at least 20% of mother-infant dyads that self-report as racial/ethnic minorities. Equal enrollment of male and female infants is anticipated across atopic and non-atopic groups. To encourage breastfeeding beyond 16 weeks all participants will have access to on-site lactation support at each study visit. A balanced sub-analysis of 66 atopic and 66 non-atopic dyads may be utilized to match for breastfeeding duration and frequency).

Ages

0 to 7 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

allergic disease atopic eczema atopic IgE-mediated allergic disorder Eczema food allergy Respiratory Sounds

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis (eczema) ATOPY Food allergy in infants Wheezing

Contacts and locations

Locations

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.