Peanut AllergyEPINCT03019328
Early Peanut Introduction: Translation to Clinical Practice
An observational study of Peanut Allergy, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy is a major step towards prevention of food allergy. However, because that finding was from a clinical trial in a very select population, there are several major questions that must be answered in order to implement these… Read more about this study
- Who is it for?
- Ages 4 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Peanut in diet
- How many people
- 333 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to 24 Mar 2023
- 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 11 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants age 4 monhts to 11 months
Who may be able to join
- Infants age 4-11 months
- Have at least one of the following criteria:
- physician diagnosis of milk, egg or other non-peanut food allergy,
- at least moderate eczema as defined by a SCORAD score of at least 25 on present or previous evaluation, OR a rash that required the application of topical creams or ointments containing corticosteroids or calcineurin inhibitors and occurred on at least 7 days on two separate occasions, or is described by the parent or guardian as "a bad rash in joints or creases" or "a bad itchy, dry, oozing or crusted rash".
- a first degree relative (parents or siblings) with either a physician diagnosis of IgE mediated peanut allergy OR reported history of symptoms consistent with IgE mediated peanut allergy (onset of symptoms within 2 hours of exposure, AND symptoms of urticaria, angioedema, wheezing, vomiting, or abdominal pain with exposure, AND no subsequent exposure to peanut without symptoms).
Who cannot join
- History of feeding problems
- History of eosinophilic gastro-intestinal disease
- Significant medical history (aside from eczema, food allergy or history of wheeze)
- History of peanut reactions or tolerance prior to baseline screening
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy is a major step towards prevention of food allergy. However, because that finding was from a clinical trial in a very select population, there are several major questions that must be answered in order to implement these findings into clinical practice without causing more harm than good. These questions include who, if anyone, should be screened prior to early introduction for peanut allergy, how this screening should be done, and what quantity of peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer these critical questions so that the potential of these recent findings can be realized. To that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of peanut IgE, and then will be followed for assessment of peanut consumption and development of peanut allergy until 3 years of age.
Read the detailed description
400 infants aged 4-11 months from three high risk groups will be enrolled in a prospective observational study. All subjects will have a baseline research clinic visit, where they will be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of peanut immunoglobulin E (IgE). Based on the baseline oral food challenge, the participants will be advised to begin introducing peanut following the current practice guidelines. Participants will then be followed until 30 months of age with two clinic visits and regular monitoring of peanut consumption.
- Conditions
- Peanut Allergy
- Being tested
- Peanut in diet
- Keywords
- peanut allergy, food allergens, atopic dermatitis, eczema, infant food allergy testing, skin prick testing, peanut IgE, early peanut introduction, food allergy prevention
- Medical subject headings
- Peanut Hypersensitivity, Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut in dietOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of infants with peanut allergy at baseline
Percentage of infants who fail the peanut challenge at the baseline visit
Measured: Baseline
Secondary outcomes (6)
Compare results of peanut skin prick test to peanut challenge outcomes among the high risk infants
Results of peanut skin prick tests compared to peanut challenge among the high risk infants
Measured: baseline
Compare results of anti-peanut IgE testing to peanut challenge outcomes among the high risk infants
Results of anti-peanut IgE testing compared to peanut challenge among the high risk infants
Measured: baseline
Compare results of anti-Ara h2 IgE testing to peanut challenge outcomes among the high risk infants
Results of anti-Ara h2 IgE testing compared to peanut challenge among the high risk infants
Measured: baseline
Percent of infants who develop peanut allergy by age 30 months
Percent of infants at risk who develop peanut allergy during the study window (30 months)
Measured: 30 months
Percent of infants with a skin prick test of 3 mm or more at baseline who develop peanut allergy
Percent of infants with a positive skin prick test who develop peanut allergy during the study window (30 months)
Measured: 30 months
Peanut levels in bedroom dust as measured by home dust collection
Peanut levels will be tested by Elisa in bed dust collected by patients using a DUSTREAM(R) vacuum adaptor.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion31 Oct 2022
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Corinne Keet, MD, Principal investigator, Johns Hopkins UniversityRobert Wood, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019328
- Sponsor's protocol ID
- IRB00095833
- Other IDs
- 1U01AI125290
- Acronym
- EPI
- Status last verified
- Apr 2023
- First submitted
- 10 Jan 2017
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Peanut Introduction: Translation to Clinical Practice
- ClinicalTrials.gov ID
- NCT03019328
- Acronym / sponsor ID
- EPI / IRB00095833
- Conditions
- Peanut Allergy
- Keywords
- peanut allergy, food allergens, atopic dermatitis, eczema, infant food allergy testing, skin prick testing, peanut IgE, early peanut introduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Massachusetts General Hospital
- Study start
- Dec 2016 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 12 Jan 2017 (estimated)
- 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 recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy is a major step towards prevention of food allergy. However, because that finding was from a clinical trial in a very select population, there are several major questions that must be answered in order to implement these findings into clinical practice without causing more harm than good. These questions include who, if anyone, should be screened prior to early introduction for peanut allergy, how this screening should be done, and what quantity of peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer these critical questions so that the potential of these recent findings can be realized. To that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of peanut IgE, and then will be followed for assessment of peanut consumption and development of peanut allergy until 3 years of age.
Detailed description
400 infants aged 4-11 months from three high risk groups will be enrolled in a prospective observational study. All subjects will have a baseline research clinic visit, where they will be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of peanut immunoglobulin E (IgE). Based on the baseline oral food challenge, the participants will be advised to begin introducing peanut following the current practice guidelines. Participants will then be followed until 30 months of age with two clinic visits and regular monitoring of peanut consumption.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants age 4 monhts to 11 months
Key inclusion criteria (5 listed)
- Infants age 4-11 months
- Have at least one of the following criteria:
Key exclusion criteria (4 listed)
- History of feeding problems
- History of eosinophilic gastro-intestinal disease
- Significant medical history (aside from eczema, food allergy or history of wheeze)
- History of peanut reactions or tolerance prior to baseline screening
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 |
|---|---|---|
| Peanut in diet | Other | – |
Primary outcome
Percent of infants with peanut allergy at baseline
Time frame: Baseline
Percentage of infants who fail the peanut challenge at the baseline visit
6 secondary outcomes
Compare results of peanut skin prick test to peanut challenge outcomes among the high risk infants
Time frame: baseline
Compare results of anti-peanut IgE testing to peanut challenge outcomes among the high risk infants
Time frame: baseline
Compare results of anti-Ara h2 IgE testing to peanut challenge outcomes among the high risk infants
Time frame: baseline
Percent of infants who develop peanut allergy by age 30 months
Time frame: 30 months
Percent of infants with a skin prick test of 3 mm or more at baseline who develop peanut allergy
Time frame: 30 months
Peanut levels in bedroom dust as measured by home dust collection
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Peanut Allergy
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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.
Corinne Keet, MD principal investigator
Johns Hopkins University
Robert Wood, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peanut Allergy, run by Johns Hopkins University at 2 sites 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of infants with peanut allergy at baseline (time frame: Baseline). 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 11 Apr 2023.