Peanut AllergyNCT03546413
Follow up of LEAP Participants and Their Families
An observational study of Peanut Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United Kingdom.
Trial summary
This prospective, cross-sectional study was designed to improve understanding of how early-life introduction of peanuts may promote the maintenance of tolerance in adolescence and will serve as an additional safety evaluation of the original nutritional intervention. Read more about this study
- Who is it for?
- Ages 0 months and older
- Conditions the study is for
- Peanut Allergy
- How many people
- 1,868 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jul 2018to 31 Aug 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 0 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Original Learning Early About Peanut (LEAP) allergy study participants (NCT00329784): at high risk for peanut allergy, given the presence of severe eczema, egg allergy, or both * Siblings of LEAP participants * Parents of LEAP participants
Who may be able to join
- Participation in LEAP;
- At least 9.5 years of age
- Willingness to participate in at least one study data collection (i.e. questionnaire, skin pricking testing, or blood draw) procedure; and
- Assent by child and informed consent by parent or legal guardian.
- Sibling of LEAP participant;
- Willingness to participate in at least one study data collection (i.e. questionnaire, skin pricking testing, or blood draw); and
Show all 10Show fewer
- Assent by child and informed consent by parent or legal guardian if child is younger than 16; siblings aged 16 and over will provide their own consent.
- Biological parent of LEAP participant;
- Willingness to participate in at least one study data collection (i.e. questionnaire, skin pricking testing, or blood draw); and
- Informed consent (for participants only returning a Questionnaire, informed consent will be implied).
Who cannot join
- There are no exclusion criteria for LEAP Participants, LEAP Siblings, LEAP Parents
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Evelina London Children's Hospital
London, SE1 7EH
About this study
Official title: Follow up of Learning Early About Peanut Allergy (LEAP) Participants and Their Families: LEAP Trio (ITN070AD)
This prospective, cross-sectional study was designed to improve understanding of how early-life introduction of peanuts may promote the maintenance of tolerance in adolescence and will serve as an additional safety evaluation of the original nutritional intervention.
Read the detailed description
Background: Food allergies and specifically peanut allergy (PA) are increasingly common conditions and are an important public health concern. Dietary avoidance of peanut in early life has been recommended in many countries. However, there is evidence that the prevalence of PA is decreased in countries where children are fed peanut beginning at an early age.
The LEAP (Learning Early About Peanut allergy) Study (Protocol ITN032AD, NCT00329784) demonstrated that the early consumption of peanut in high-risk infants successfully reduced the prevalence of peanut allergy at five years of age when compared to peanut avoidance. The LEAP-On Study (Protocol ITN049AD, NCT01366846) was a follow-on study to LEAP and demonstrated that children who consumed peanut in the LEAP study remained protected against developing peanut allergy after cessation of peanut consumption for a period of 12 months.
This LEAP Trio cohort study, a longer-term follow-up of the LEAP study participants, assessed whether the benefits of regular early-life peanut consumption are maintained over many years when peanut consumption is ad libitum (in the amount and frequency chosen by the individual participant).
The three cohorts in LEAP-Trio include:
- LEAP Participants (NCT00329784, NCT01366846)
- their Siblings and
- their Parents
The study began on July 5, 2018, with data collection continuing until August 31, 2022. This allowed for the enrollment of former LEAP participants aged 12 years.:
- The enrollment phase was 217 weeks (4 years, 2 months).
--The LEAP siblings and parents were enrolled concurrently with the LEAP participant.
- Study participation was defined as a single visit (Visit 144 months); however, more than one clinic appointment might have been required to complete all assessments and were required to be completed within 8 weeks of the in-person visit. Due to COVID-19, telephone visits were undertaken when participants were not able to or did not wish to come into the clinic or have a home visit. The visit window did not apply to the telephone visit. Participants who underwent a telephone visit were invited to subsequently undergo an in-person clinic visit or home visit.
Participant assessments included general medical, -dietary, -allergy (including but not limited to oral peanut food challenges for former LEAP participants and their siblings), and mechanistic assessments (involving the collection of biological specimens, a blood draw, skin prick testing, as examples, to explore hypotheses related to potential mechanisms of peanut allergy).
- Conditions
- Peanut Allergy
- Keywords
- food, peanut, allergy, prevention
- Medical subject headings
- Peanut Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LEAP Participants: Peanut Avoidance | Participants of the LEAP study who enrolled in the LEAP Trio study and were originally randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study. | |
| LEAP Participants: Peanut Consumption | Participants of the LEAP study who enrolled in the LEAP Trio study and were originally randomized to the Peanut Consumption treatment arm upon entry into the LEAP study. | |
| Younger Siblings: Peanut Avoidance | Participants enrolled in the LEAP Trio study who are younger siblings of a LEAP Participant who was randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study. | |
| Younger Siblings: Peanut Consumption | Participants enrolled in the LEAP Trio study who are younger siblings of a LEAP Participant who was randomized to the Peanut Consumption treatment arm upon entry into the LEAP study. | |
| Older Siblings: Peanut Avoidance | Participants enrolled in the LEAP Trio study who are older siblings of a LEAP Participant who was randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study. | |
| Older Siblings: Peanut Consumption | Participants enrolled in the LEAP Trio study who are older siblings of a LEAP Participant who was randomized to the Peanut Consumption treatment arm upon entry into the LEAP study. | |
| Parents: Peanut Avoidance | Participants enrolled in the LEAP Trio study who are parents of a LEAP Participant who was randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study. | |
| Parents: Peanut Consumption | Participants enrolled in the LEAP Trio study who are parents of a LEAP Participant who was randomized to the Peanut Consumption treatment arm upon entry into the LEAP study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of LEAP Participants With Peanut Allergy
Peanut allergy status at LEAP Trio Visit 144 was determined by peanut challenge where possible. Participants who met criteria for peanut oral allergy syndrome in the absence of primary peanut allergy were not considered peanut allergic. Individuals who reported consuming at least 2 g of peanut protein without reaction on at least one occasion in the last year were considered peanut tolerant. If oral challenge was not possible and participants did not meet the above criteria for tolerance, peanut allergy status was determined by an internally and externally validated novel peanut allergy prediction model using data for peanut wheal size (mm), peanut specific IgE (kU/L), Ara h1 (kU/L), Ara h2 (kU/L) and Ara h3 (kU/L)
Measured: Assessments were performed on consented LEAP Participants at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of Younger Siblings With Peanut Sensitization
Peanut sensitization in the siblings of the LEAP Participants was defined as meeting at least one of the following criteria:
Specific-IgE ≥0.35 kU/L or Specific-IgE to individual peanut component Ara h2 ≥0.1 kU/L, or Skin prick test wheal to peanut ≥3mm
Measured: Assessments were performed on consented siblings at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Secondary outcomes (10)
Average Weekly Peanut Protein Consumption of LEAP Participants, Younger Siblings, Older Siblings and Parents
At LEAP Trio Visit 144, participants were asked to provide responses to questions about their peanut protein consumption. Responses obtained at LEAP Trio Visit 144 were based on the recollection of peanut consumption during the 4 weeks prior to the LEAP Trio study Visit 144.
Measured: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Peanut Skin Prick Test Wheal Size for LEAP Participants, Younger Siblings, Older Siblings and Parents
Skin prick tests were performed to assess participants for potential peanut allergy, select food allergens, and select aeroallergens
Measured: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Peanut Specific-IgE Measurements for the LEAP Participants, Younger Siblings, Older Siblings, and Parents
Participants had blood draws to assess specific-IgE measurements to peanut, select food allergens and select aeroallergens
Measured: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
SCORAD Score for the Eczema Severity in LEAP Participants, Younger Siblings and Older Siblings
Eczema severity was assessed using a modified Scoring Atopic Dermatitis (SCORAD) assessment. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.
Measured: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Eczema
Participants were classified as having eczema using standard methodology. Participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD) and using participant report of a history of eczema. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.
Measured: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Asthma
Participants were classified as having asthma if they meet at least one of the following definitions:
- Participant report of cough, wheeze, or shortness of breath that was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months; or required one visit to a physician in the previous 24 months; or occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months.
- Participant report of an asthma diagnosis with current use of asthma medications (short-acting beta-agonist or controller)
- Participant report of transient wheeze on exposure to a suspected allergen with confirmatory allergy tests
Measured: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Perennial Rhinitis
Participants were considered to have perennial rhinitis if they demonstrated a sensitization to the aeroallergen and clinical history of rhinoconjunctivitis symptoms experienced when exposed to the relevant allergen. Sensitization to the relevant allergen was defined as:
- Allergen specific IgE ≥ 0.35 kU/L, or
- Skin prick test wheal size to allergen ≥ 3 mm.
Measured: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings and Parents With Seasonal Rhinitis
Participants were considered to have seasonal rhinitis if they demonstrated a sensitization to a seasonal aeroallergen and clinical history of rhinoconjunctivitis symptoms experienced when exposed to the allergen during the relevant season. Sensitization to the relevant allergen was defined as:
- Allergen specific IgE ≥ 0.35 kU/L, or
- Skin prick test wheal size to allergen ≥ 3 mm
Measured: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Younger Siblings, Older Siblings and Parents With Peanut Allergy
Peanut allergy status at LEAP Trio Visit 144 was determined by peanut challenge where possible. Participants who met criteria for peanut oral allergy syndrome in the absence of primary peanut allergy were not considered peanut allergic. Individuals who reported consuming at least 2 g of peanut protein without reaction on at least one occasion in the last year were considered peanut tolerant. If oral challenge was not possible and participants did not meet the above criteria for tolerance, peanut allergy status was determined by an internally and externally validated novel peanut allergy prediction model using data for peanut wheal size (mm), peanut specific IgE (kU/L), Ara h1 (kU/L), Ara h2 (kU/L) and Ara h3 (kU/L)
Measured: Assessments were performed on consented family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings and Older Siblings With at Least One Peanut-related Adverse Event
Peanut-related adverse events were reported from reactions experienced during or within 30 days after the LEAP Trio Visit 144 peanut oral food challenge (peanut OFC)
Measured: Within 30 days after peanut OFC performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start5 Jul 2018
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Cross-sectional
- Enrolment
- 1,868 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Gideon Lack, MD, Study chair, Evelina Children's Hospital, Guy's and St. Thomas's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546413
- Sponsor's protocol ID
- DAIT ITN070AD
- Other IDs
- LEAP Trio, NIAID CRMS ID#: 38498
- Status last verified
- Mar 2024
- First submitted
- 17 Apr 2018
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Publications
Sever ML, Calatroni A, Roberts G, du Toit G, Bahnson HT, Radulovic S, Larson D, Byron M, Santos AF, Huffaker MF, Wheatley LM, Lack G. Developing a Prediction Model for Determination of Peanut Allergy Status in the Learning Early About Peanut Allergy (LEAP) Studies. J Allergy Clin Immunol Pract. 2023 Jul;11(7):2217-2227.e9. doi: 10.1016/j.jaip.2023.04.032. Epub 2023 May 3.
PubMed 37146884Du Toit G, Huffaker MF, Radulovic S, Feeney M, Fisher HR, Byron M, Dunaway L, Calatroni A, Johnson M, Foong RX, Marques-Mejias A, Bartha I, Basting M, Brough HA, Baloh C, Laidlaw TM, Bahnson HT, Roberts G, Plaut M, Wheatley LM, Lack G; Immune Tolerance Network LEAP-Trio Trial Team. Follow-up to Adolescence after Early Peanut Introduction for Allergy Prevention. NEJM Evid. 2024 Jun;3(6):EVIDoa2300311. doi: 10.1056/EVIDoa2300311. Epub 2024 May 28.
PubMed 38804779
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Learning Early About Peanut Allergy (LEAP) Participants and Their Families: LEAP Trio (ITN070AD)
- ClinicalTrials.gov ID
- NCT03546413
- Acronym / sponsor ID
- DAIT ITN070AD
- Conditions
- Peanut Allergy
- Keywords
- food, peanut, allergy, prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,868 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), PPD Development, LP
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Posted 29 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, cross-sectional study was designed to improve understanding of how early-life introduction of peanuts may promote the maintenance of tolerance in adolescence and will serve as an additional safety evaluation of the original nutritional intervention.
Detailed description
Background: Food allergies and specifically peanut allergy (PA) are increasingly common conditions and are an important public health concern. Dietary avoidance of peanut in early life has been recommended in many countries. However, there is evidence that the prevalence of PA is decreased in countries where children are fed peanut beginning at an early age.
The LEAP (Learning Early About Peanut allergy) Study (Protocol ITN032AD, NCT00329784) demonstrated that the early consumption of peanut in high-risk infants successfully reduced the prevalence of peanut allergy at five years of age when compared to peanut avoidance. The LEAP-On Study (Protocol ITN049AD, NCT01366846) was a follow-on study to LEAP and demonstrated that children who consumed peanut in the LEAP study remained protected against developing peanut allergy after cessation of peanut consumption for a period of 12 months.
This LEAP Trio cohort study, a longer-term follow-up of the LEAP study participants, assessed whether the benefits of regular early-life peanut consumption are maintained over many years when peanut consumption is ad libitum (in the amount and frequency chosen by the individual participant).
The three cohorts in LEAP-Trio include:
- LEAP Participants (NCT00329784, NCT01366846)
- their Siblings and
- their Parents
The study began on July 5, 2018, with data collection continuing until August 31, 2022. This allowed for the enrollment of former LEAP participants aged 12 years.:
- The enrollment phase was 217 weeks (4 years, 2 months).
--The LEAP siblings and parents were enrolled concurrently with the LEAP participant.
- Study participation was defined as a single visit (Visit 144 months); however, more than one clinic appointment might have been required to complete all assessments and were required to be completed within 8 weeks of the in-person visit. Due to COVID-19, telephone visits were undertaken when participants were not able to or did not wish to come into the clinic or have a home visit. The visit window did not apply to the telephone visit. Participants who underwent a telephone visit were invited to subsequently undergo an in-person clinic visit or home visit.
Participant assessments included general medical, -dietary, -allergy (including but not limited to oral peanut food challenges for former LEAP participants and their siblings), and mechanistic assessments (involving the collection of biological specimens, a blood draw, skin prick testing, as examples, to explore hypotheses related to potential mechanisms of peanut allergy).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| LEAP Participants: Peanut Avoidance | – | –Participants of the LEAP study who enrolled in the LEAP Trio study and were originally randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study. |
| LEAP Participants: Peanut Consumption | – | –Participants of the LEAP study who enrolled in the LEAP Trio study and were originally randomized to the Peanut Consumption treatment arm upon entry into the LEAP study. |
| Younger Siblings: Peanut Avoidance | – | –Participants enrolled in the LEAP Trio study who are younger siblings of a LEAP Participant who was randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study. |
| Younger Siblings: Peanut Consumption | – | –Participants enrolled in the LEAP Trio study who are younger siblings of a LEAP Participant who was randomized to the Peanut Consumption treatment arm upon entry into the LEAP study. |
| Older Siblings: Peanut Avoidance | – | –Participants enrolled in the LEAP Trio study who are older siblings of a LEAP Participant who was randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study. |
| Older Siblings: Peanut Consumption | – | –Participants enrolled in the LEAP Trio study who are older siblings of a LEAP Participant who was randomized to the Peanut Consumption treatment arm upon entry into the LEAP study. |
| Parents: Peanut Avoidance | – | –Participants enrolled in the LEAP Trio study who are parents of a LEAP Participant who was randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study. |
| Parents: Peanut Consumption | – | –Participants enrolled in the LEAP Trio study who are parents of a LEAP Participant who was randomized to the Peanut Consumption treatment arm upon entry into the LEAP study. |
Who may qualify
- Ages
- 0 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Original Learning Early About Peanut (LEAP) allergy study participants (NCT00329784): at high risk for peanut allergy, given the presence of severe eczema, egg allergy, or both * Siblings of LEAP participants * Parents of LEAP participants
Key inclusion criteria (10 listed)
- Participation in LEAP;
- At least 9.5 years of age
- Willingness to participate in at least one study data collection (i.e. questionnaire, skin pricking testing, or blood draw) procedure; and
- Assent by child and informed consent by parent or legal guardian.
- Sibling of LEAP participant;
Key exclusion criteria (1 listed)
- There are no exclusion criteria for LEAP Participants, LEAP Siblings, LEAP Parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of LEAP Participants With Peanut Allergy
Time frame: Assessments were performed on consented LEAP Participants at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Peanut allergy status at LEAP Trio Visit 144 was determined by peanut challenge where possible. Participants who met criteria for peanut oral allergy syndrome in the absence of primary peanut allergy were not considered peanut allergic. Individuals who reported consuming at least 2 g of peanut protein without reaction on at least one occasion in the last year were considered peanut tolerant. If oral challenge was not possible and participants did not meet the above criteria for tolerance, peanut allergy status was determined by an internally and externally validated novel peanut allergy prediction model using data for peanut wheal size (mm), peanut specific IgE (kU/L), Ara h1 (kU/L), Ara h2 (kU/L) and Ara h3 (kU/L)
Percentage of Younger Siblings With Peanut Sensitization
Time frame: Assessments were performed on consented siblings at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Peanut sensitization in the siblings of the LEAP Participants was defined as meeting at least one of the following criteria: Specific-IgE ≥0.35 kU/L or Specific-IgE to individual peanut component Ara h2 ≥0.1 kU/L, or Skin prick test wheal to peanut ≥3mm
10 secondary outcomes
Average Weekly Peanut Protein Consumption of LEAP Participants, Younger Siblings, Older Siblings and Parents
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Peanut Skin Prick Test Wheal Size for LEAP Participants, Younger Siblings, Older Siblings and Parents
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Peanut Specific-IgE Measurements for the LEAP Participants, Younger Siblings, Older Siblings, and Parents
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
SCORAD Score for the Eczema Severity in LEAP Participants, Younger Siblings and Older Siblings
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Eczema
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Asthma
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Perennial Rhinitis
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings and Parents With Seasonal Rhinitis
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Younger Siblings, Older Siblings and Parents With Peanut Allergy
Time frame: Assessments were performed on consented family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings and Older Siblings With at Least One Peanut-related Adverse Event
Time frame: Within 30 days after peanut OFC performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37146884Sever ML, Calatroni A, Roberts G, du Toit G, Bahnson HT, Radulovic S, Larson D, Byron M, Santos AF, Huffaker MF, Wheatley LM, Lack G. Developing a Prediction Model for Determination of Peanut Allergy Status in the Learning Early About Peanut Allergy (LEAP) Studies. J Allergy Clin Immunol Pract. 2023 Jul;11(7):2217-2227.e9. doi: 10.1016/j.jaip.2023.04.032. Epub 2023 May 3.
- Derived from this study: PubMed 38804779Du Toit G, Huffaker MF, Radulovic S, Feeney M, Fisher HR, Byron M, Dunaway L, Calatroni A, Johnson M, Foong RX, Marques-Mejias A, Bartha I, Basting M, Brough HA, Baloh C, Laidlaw TM, Bahnson HT, Roberts G, Plaut M, Wheatley LM, Lack G; Immune Tolerance Network LEAP-Trio Trial Team. Follow-up to Adolescence after Early Peanut Introduction for Allergy Prevention. NEJM Evid. 2024 Jun;3(6):EVIDoa2300311. doi: 10.1056/EVIDoa2300311. Epub 2024 May 28.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Immune Tolerance Network (ITN)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
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.
Gideon Lack, MD study chair
Evelina Children's Hospital, Guy's and St. Thomas's NHS Foundation Trust
1 site 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 National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United Kingdom.
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 10 inclusion and 1 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 29 Mar 2024. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 29 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of LEAP Participants With Peanut Allergy (time frame: Assessments were performed on consented LEAP Participants at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).). 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?
On the ClinicalTrials.gov record for NCT03546413, which also lists 2 linked publications.
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 29 Mar 2024.