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Breast milk allergy clues: study scrapped before it began

NCT ID NCT06765213

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to see if common food allergens like milk, egg, and peanut can pass through breast milk and cause allergies in infants. Researchers planned to test breast milk samples and check babies for sensitization using skin prick and blood tests. However, the study was withdrawn before any participants were enrolled, so no data was collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help understand how food allergies develop in breastfed infants and guide early prevention strategies.
What could go wrong
This is a very small pilot study that was withdrawn before enrolling anyone, so no results are available. It may not provide clear answers.

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.

Started

Mar 2024

Finished

Feb 2026

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

Infants at 4 months of age up to 24 months of age.

Ages

4 to 24 months

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: 1. Pregnant or post-partum females who plan to exclusively breastfeed and their infants who have completed at least 37 weeks of gestation 1. These are vulnerable populations 2. Our study involves breastmilk analysis, which we need postpartum mothers to supply. 3. (Parent) Testing will be done solely on breastmilk samples, with only potential dietary intervention done to the parent postpartum depending on the outcomes of the infant and breastmilk. 4. (Infant) In order to determine if allergens in breastmilk play a role in food allergen sensitization, we need to test the infants prior to the introduction of solid foods. 2. Personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, food allergies, and atopic dermatitis 3. Maternal diet must include hen's egg, cow's milk, and wheat products. Exclusion Criteria: 1. No maternal history of atopic disease 2. Exclusive formula feeding 3. Maternal diet devoid of hen's egg, cow's milk, or wheat, for example, vegan diets and persons with gluten sensitivity.

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Conditions

The condition(s) this trial relates to.

Breast Feeding Breast Milk Expression Egg Hypersensitivity food allergy Milk Hypersensitivity Wheat Hypersensitivity

As listed by the trial registrant

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

Contacts and locations

Locations

  • Pediatric Sub Specialty Clinic at Bay Colony

    RECRUITING

    League City, Texas, 77573, United States

More trials for these conditions

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