Allergy and ImmunologyESCAPENCT06260956
Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg
A study testing Consumption and Avoidance in people with Allergy and Immunology and Peanut and Nut Allergy, run by University of Rochester at 1 site in United States.
Trial summary
Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during… Read more about this study
- Who is it for?
- Ages 1 day and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Allergy and Immunology, Peanut and Nut Allergy, Egg Allergy
- What is being tested?
- Consumption and Avoidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 day and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- o Subject must be able to understand and provide informed consent.
- Mothers will be English-speaking adults, 18 years or older. (Spanish speaking adults may be included after consent document is translated and Spanish speaking study representatives are available to conduct and answer questions during informed consent process and for study follow up.)
- Maternal consent must be provided for infants.
- Pregnant women from the time pregnancy is confirmed until 27 weeks of gestation.
- Self-reported at time of enrollment:
- no chronic inflammatory conditions that require long-term systemic immunosuppressive medications in first or second trimester
Show all 12Show fewer
- carrying a fetus with a first-degree relative (i.e., mother, father, full sibling) with any self-reported or physician-diagnosed allergic disease (asthma, allergic rhinitis, atopic dermatitis, or food allergy).
- Intend to give their infant their own breast milk for more than 3 months.
- Can confidently say they have eaten PN and egg and have tolerated consumption with no food allergy reactions.
- Willing to be randomized to consumption or avoidance diet.
- Uncomplicated pregnancy (no gestational diabetes, no preeclampsia, no hyperemesis gravidarum), self-reported at time of enrollment.
- Infants will be minimum age, 1 day (birth), through 365 days (12 months).
Who cannot join
- Inability or unwillingness of subject to give written informed consent or comply with study protocol.
- Known history of renal/liver/cardiac insufficiency in the mother or infant.
- Pregnant women with PN or egg allergy.
- Pregnant women who refuse to eat PN (or peanut products) and/or eggs.
- Physician diagnosed immunodeficiency in the mother or infant.
- Current, diagnosed, mental illness or current, diagnosed, or self-reported, drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements.
- Past or current medical problems or findings from medical history that are not listed above, which, in the opinion of the investigator, may pose additional risks to the mother or infant from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Kirsi Jarvinen-Seppo, MD, PhD
About this study
Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding.
Read the detailed description
The goals of this study include defining the role of egg and peanut consumption or avoidance during pregnancy and via human milk in food sensitization and identifying the underlying biological mechanisms leading to sensitization or tolerance. The study population will include 500 mother/infant dyads who plan to exclusively feed breastmilk to healthy infants. We expect approximately 25% will be recruited locally and the rest from across the United States. This is a national, parallel, two arm, one-to-one allocation, single blinded, randomized controlled trial. Each arm of the study defines maternal diet from 27 weeks gestation through their baby's fourth month with some consuming peanut and egg and some avoiding these foods.
- Conditions
- Allergy and Immunology, Peanut and Nut Allergy, Egg Allergy, Food Allergy in Infants, Food Allergy Peanut
- Being tested
- Consumption, Avoidance
- Medical subject headings
- Hypersensitivity, Nut and Peanut Hypersensitivity, Egg Hypersensitivity, Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConsumptionBehavioural
Subjects consume peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.
AvoidanceBehavioural
Subjects avoid eating peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Consumption | Active comparator | Subjects must consume peanuts and peanut products and egg and egg products. Receives: Behavioral: Consumption |
| Arm 2 Avoidance | Active comparator | Subjects must avoid eating peanuts and peanut products and egg and egg products. Receives: Behavioral: Avoidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Egg or peanut sensitization
Determine the proportion of high-risk infants who have developed egg or peanut sensitization at four months (prior to introduction of these foods to the infant).
Measured: four months
Secondary outcomes (4)
Peanut and egg specific IgG and IgG4
Levels of infant peanut and egg specific IgG and IgG4
Measured: four months
Antibodies in maternal blood
Quantify egg- and PN-specific IgG and IgG4 antibody concentrations in maternal blood measured during pregnancy and at four months.
Measured: four months
Egg allergy
Questionnaire for parents to report any signs of egg allergy in their child.
Measured: 12 months
Egg and peanut specific IgE
Measure levels of infant egg- and peanut-specific IgE.
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Aug 2025
- Primary completionJun 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy and ImmunologyStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National, parallel, two arm (one-to-one allocation), single blinded, randomized controlled trial.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsi Jarvinen-Seppo, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260956
- Sponsor's protocol ID
- U01-ROC-001
- Other IDs
- 1U01AI173032
- Acronym
- ESCAPE
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per NIH policy
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg
- ClinicalTrials.gov ID
- NCT06260956
- Acronym / sponsor ID
- ESCAPE / U01-ROC-001
- Conditions
- Allergy and Immunology, Peanut and Nut Allergy, Egg Allergy, Food Allergy in Infants, Food Allergy Peanut
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Feb 2024 (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.
Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding.
Detailed description
The goals of this study include defining the role of egg and peanut consumption or avoidance during pregnancy and via human milk in food sensitization and identifying the underlying biological mechanisms leading to sensitization or tolerance. The study population will include 500 mother/infant dyads who plan to exclusively feed breastmilk to healthy infants. We expect approximately 25% will be recruited locally and the rest from across the United States. This is a national, parallel, two arm, one-to-one allocation, single blinded, randomized controlled trial. Each arm of the study defines maternal diet from 27 weeks gestation through their baby's fourth month with some consuming peanut and egg and some avoiding these foods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- National, parallel, two arm (one-to-one allocation), single blinded, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Consumption | Active comparator | Behavioral: ConsumptionSubjects must consume peanuts and peanut products and egg and egg products. |
| Arm 2 Avoidance | Active comparator | Behavioral: AvoidanceSubjects must avoid eating peanuts and peanut products and egg and egg products. |
Who may qualify
- Ages
- 1 day and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- o Subject must be able to understand and provide informed consent.
- Mothers will be English-speaking adults, 18 years or older. (Spanish speaking adults may be included after consent document is translated and Spanish speaking study representatives are available to conduct and answer questions during informed consent process and for study follow up.)
- Maternal consent must be provided for infants.
- Pregnant women from the time pregnancy is confirmed until 27 weeks of gestation.
- Self-reported at time of enrollment:
Key exclusion criteria (7 listed)
- Inability or unwillingness of subject to give written informed consent or comply with study protocol.
- Known history of renal/liver/cardiac insufficiency in the mother or infant.
- Pregnant women with PN or egg allergy.
- Pregnant women who refuse to eat PN (or peanut products) and/or eggs.
- Physician diagnosed immunodeficiency in the mother or infant.
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 |
|---|---|---|
| ConsumptionSubjects consume peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant. | Behavioural | Arm 1 Consumption |
| AvoidanceSubjects avoid eating peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant. | Behavioural | Arm 2 Avoidance |
Primary outcome
Egg or peanut sensitization
Time frame: four months
Determine the proportion of high-risk infants who have developed egg or peanut sensitization at four months (prior to introduction of these foods to the infant).
4 secondary outcomes
Peanut and egg specific IgG and IgG4
Time frame: four months
Antibodies in maternal blood
Time frame: four months
Egg allergy
Time frame: 12 months
Egg and peanut specific IgE
Time frame: four months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. Per NIH policy
Related trials for Allergy and Immunology
RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
RecruitingPhase 3
Donidalorsen Treatment in Children With Hereditary Angioedema
Hereditary Angioedema (HAE)
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
RecruitingObservational study
A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
Hereditary Angioedema (HAE)
Active, not recruitingPhase 3
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
Hereditary Angioedema
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption and Avoidance in people with Allergy and Immunology and Peanut and Nut Allergy, run by University of Rochester at 1 site in United States.
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 12 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison W Leadley, MPH (585-275-4640, allison_leadley@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Egg or peanut sensitization (time frame: four months). 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 8 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.