Food Allergy in InfantsNCT06765213
Human Breast Milk's Role in Food Allergy Development
An observational study of Food Allergy in Infants and Food Allergen Sensitisation, run by The University of Texas Medical Branch, Galveston.
Trial summary
The goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants. The main question[s] it aims to answer are: Will major allergens for milk, egg, and peanut be passed on to infants in breast milk? Will the infants become sensitized to and develop… Read more about this study
- Who is it for?
- Ages 4 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy in Infants, Food Allergen Sensitisation, Breast Feeding, Exclusive
- What is being tested?
- Open Ended Oral Food Challenge and Early Introduction
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 8 Mar 2024to 19 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants at 4 months of age up to 24 months of age.
Who may be able to join
- Pregnant or post-partum females who plan to exclusively breastfeed and their infants who have completed at least 37 weeks of gestation
- These are vulnerable populations
- Our study involves breastmilk analysis, which we need postpartum mothers to supply.
- (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.
- (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.
- Personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, food allergies, and atopic dermatitis
- Maternal diet must include hen's egg, cow's milk, and wheat products.
Who cannot join
- No maternal history of atopic disease
- Exclusive formula feeding
- Maternal diet devoid of hen's egg, cow's milk, or wheat, for example, vegan diets and persons with gluten sensitivity.
About this study
Official title: Evaluation of Human Breast Milk and Its Role in Early Food Allergen Sensitization in Infants
The goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants.
The main question[s] it aims to answer are:
Read more
- Will major allergens for milk, egg, and peanut be passed on to infants in breast milk?
- Will the infants become sensitized to and develop an allergy to the food allergens found in breast milk?
- Will early introduction interventions prevent the development of these food allergies?
Participants will
- provide breast milk sample (s) for testing for food allergens
- Infants will be tested for sensitization via skin prick and blood testing
- Infants will be challenge with suspected foods to determine allergy and undergo early introduction procedures
Read the detailed description
Recruitment of subjects will be open enrollment pregnant or post-partum women with a personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, atopic dermatitis (eczema), and/or food allergy who are exclusively breastfeeding.
Mothers will provide a breastmilk sample(s) for testing of allergens to milk, egg, and wheat. Prior to the introduction of solid foods, infants will need to be tested for sensitization to milk, egg, and wheat via skin prick testing and blood allergy testing.
Infants that are negative for sensitization will undergo introduction of these foods per standard practice. Infants that are positive for sensitization will undergo an office food challenge for those foods that they are sensitized to. A positive food challenge is diagnostic for a food allergy and they will be managed according to standard practice. A negative food challenge means that they are not allergic, and they will undergo early introduction protocols and monitored to continued tolerance.
- Conditions
- Food Allergy in Infants, Food Allergen Sensitisation, Breast Feeding, Exclusive, Breastmilk Collection
- Being tested
- Open Ended Oral Food Challenge, Early Introduction
- Keywords
- food allergy, breastmilk allergen testing, food allergen sensitization, cow milk allergy, egg allergy, wheat allergy
- Medical subject headings
- Breast Feeding, Breast Milk Expression, Food Hypersensitivity, Milk Hypersensitivity, Egg Hypersensitivity, Wheat Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Ended Oral Food ChallengeDiagnostic test
Allergens determined to be sensitized will be brought in for an oral challenge to that food.
Early IntroductionOther
Infants that are not sensitized will have the food introduced to their diet at regular intervals.
| Study group | Role | What they receive |
|---|---|---|
| Breastmilk positive/Infant sensitized | This group is for infants whose mother's breastmilk is found to be positive for allergens to either cow milk, egg, and/or wheat and who are found to be sensitized to one or more of these allergens. Receives: Diagnostic Test: Open Ended Oral Food Challenge | |
| Breastmilk positive/Infant not sensitized | This group is for infants whose mother's breastmilk is found to be positive for allergens to either cow milk, egg, and/or wheat and who are found to be not sensitized to the three allergens. Receives: Other: Early Introduction | |
| Breastmilk negative/Infant sensitized | This group is for infants whose mother's breastmilk is found to be negative for allergens to either cow milk, egg, and/or wheat and who are found to be sensitized to one or more of these allergens. Receives: Diagnostic Test: Open Ended Oral Food Challenge | |
| Breastmilk negative/Infant not sensitized | This group is for infants whose mother's breastmilk is found to be negative for allergens to either cow milk, egg, and/or wheat and who are found to be not sensitized to the three allergens. Receives: Other: Early Introduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the detection of allergens in human breast milk
A mass spectrometry will be used to detect the allergens. Mass spectrometry is a technique used in the University of Texas Medical Branch (UTMB) laboratory to detect allergens.
Measured: Baseline (4 months of age)
To assess breast milk's role in sensitization to allergens
The infant will be skin prick tested for allergens to milk, eggs, and wheat at 4 months, which is the baseline.
Measured: Baseline (4 months of age)
Secondary outcomes (1)
Number of non-sensitized participants
The infants that are non-sensitized will begin consuming milk, eggs, and wheat, and each well child check visit.
Measured: Baseline (4 months of age), 12 months of age, 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start8 Mar 2024
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in InfantsStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Allergy, Asthma, and Immunology Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765213
- Sponsor's protocol ID
- 22-0307
- Status last verified
- Feb 2026
- First submitted
- 23 Dec 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Human Breast Milk and Its Role in Early Food Allergen Sensitization in Infants
- ClinicalTrials.gov ID
- NCT06765213
- Acronym / sponsor ID
- 22-0307
- Conditions
- Food Allergy in Infants, Food Allergen Sensitisation, Breast Feeding, Exclusive, Breastmilk Collection
- Keywords
- food allergy, breastmilk allergen testing, food allergen sensitization, cow milk allergy, egg allergy, wheat allergy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Texas Allergy, Asthma, and Immunology Society
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants.
The main question[s] it aims to answer are:
- Will major allergens for milk, egg, and peanut be passed on to infants in breast milk?
- Will the infants become sensitized to and develop an allergy to the food allergens found in breast milk?
- Will early introduction interventions prevent the development of these food allergies?
Participants will
- provide breast milk sample (s) for testing for food allergens
- Infants will be tested for sensitization via skin prick and blood testing
- Infants will be challenge with suspected foods to determine allergy and undergo early introduction procedures
Detailed description
Recruitment of subjects will be open enrollment pregnant or post-partum women with a personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, atopic dermatitis (eczema), and/or food allergy who are exclusively breastfeeding.
Mothers will provide a breastmilk sample(s) for testing of allergens to milk, egg, and wheat. Prior to the introduction of solid foods, infants will need to be tested for sensitization to milk, egg, and wheat via skin prick testing and blood allergy testing.
Infants that are negative for sensitization will undergo introduction of these foods per standard practice. Infants that are positive for sensitization will undergo an office food challenge for those foods that they are sensitized to. A positive food challenge is diagnostic for a food allergy and they will be managed according to standard practice. A negative food challenge means that they are not allergic, and they will undergo early introduction protocols and monitored to continued tolerance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Breastmilk positive/Infant sensitized | – | Diagnostic Test: Open Ended Oral Food ChallengeThis group is for infants whose mother's breastmilk is found to be positive for allergens to either cow milk, egg, and/or wheat and who are found to be sensitized to one or more of these allergens. |
| Breastmilk positive/Infant not sensitized | – | Other: Early IntroductionThis group is for infants whose mother's breastmilk is found to be positive for allergens to either cow milk, egg, and/or wheat and who are found to be not sensitized to the three allergens. |
| Breastmilk negative/Infant sensitized | – | Diagnostic Test: Open Ended Oral Food ChallengeThis group is for infants whose mother's breastmilk is found to be negative for allergens to either cow milk, egg, and/or wheat and who are found to be sensitized to one or more of these allergens. |
| Breastmilk negative/Infant not sensitized | – | Other: Early IntroductionThis group is for infants whose mother's breastmilk is found to be negative for allergens to either cow milk, egg, and/or wheat and who are found to be not sensitized to the three allergens. |
Who may qualify
- Ages
- 4 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants at 4 months of age up to 24 months of age.
Key inclusion criteria (7 listed)
- Pregnant or post-partum females who plan to exclusively breastfeed and their infants who have completed at least 37 weeks of gestation
- Personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, food allergies, and atopic dermatitis
- Maternal diet must include hen's egg, cow's milk, and wheat products.
Key exclusion criteria (3 listed)
- No maternal history of atopic disease
- Exclusive formula feeding
- Maternal diet devoid of hen's egg, cow's milk, or wheat, for example, vegan diets and persons with gluten sensitivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Ended Oral Food ChallengeAllergens determined to be sensitized will be brought in for an oral challenge to that food. | Diagnostic test | Breastmilk negative/Infant sensitized, Breastmilk positive/Infant sensitized |
| Early IntroductionInfants that are not sensitized will have the food introduced to their diet at regular intervals. | Other | Breastmilk negative/Infant not sensitized, Breastmilk positive/Infant not sensitized |
Primary outcome
To assess the detection of allergens in human breast milk
Time frame: Baseline (4 months of age)
A mass spectrometry will be used to detect the allergens. Mass spectrometry is a technique used in the University of Texas Medical Branch (UTMB) laboratory to detect allergens.
To assess breast milk's role in sensitization to allergens
Time frame: Baseline (4 months of age)
The infant will be skin prick tested for allergens to milk, eggs, and wheat at 4 months, which is the baseline.
1 secondary outcome
Number of non-sensitized participants
Time frame: Baseline (4 months of age), 12 months of age, 24 months of age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy in Infants and Food Allergen Sensitisation, run by The University of Texas Medical Branch, Galveston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the detection of allergens in human breast milk (time frame: Baseline (4 months of age)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.