LEAP Trio
Research type
Research Study
Full title
Follow-up of LEAP Participants and Their Families: LEAP Trio
IRAS ID
195451
Contact name
Gideon Lack
Contact email
Sponsor organisation
National Institute of Allergy and Infectious Diseases (NIAID)
Clinicaltrials.gov Identifier
195451, IRAS Project ID
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
Research Summary
Peanut Allergy (PA) is a recognised public health concern. The early introduction of specific food allergen(s) to infant diets has proven to be a successful strategy for the prevention of food allergy. The Learning Early about Peanut Allergy (LEAP) Study demonstrated that the introduction of peanut to the infant diet before 11 months of age protected against the development of PA in a high-risk, atopic population. The LEAP-On Study demonstrated that subsequent avoidance of peanut for a year did not influence the protective effect of the intervention. All LEAP participants will now be offered enrolment in a follow-on study (LEAP Ad-Lib), a second study will assess siblings (LEAP Siblings) and a final study will assess parents (LEAP Parents). Together these three studies are known as LEAP Trio.
The primary objective of LEAP Trio is to assess whether early consumption of peanuts by high-risk infants results in a decreased risk of peanut allergy in children approximately 10 years of age, i.e. are they tolerant regardless of consumption or avoidance of peanut. The secondary objective is to determine the prevalence of sensitisation in younger siblings of LEAP participants who consumed peanut compared to younger siblings of LEAP participants who avoided peanut, i.e. does the level of peanut in the home environment influence the rates of sensitisation in younger siblings. Genetic samples from parents will be taken and stored for use in a genetic analysis comparing LEAP participants, their siblings and parents.
LEAP Trio participants will undergo allergy assessments including questionnaires, skin and blood testing and a supervised peanut oral food challenge (no OFC in parents). It will be a single site study based at the Evelina London, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).Summary of Results
The summary of study results for Protocol ITN070AD (LEAP Trio) are posted on ClinicalTrials.gov (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03546413%3Fterm%3DLEAP%2520TRio%26rank%3D1%26tab%3Dresults&data=05%7C02%7Cfulham.rec%40hra.nhs.uk%7C1d552585d8c04944f6a908dd02fe9463%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638670014617965652%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=9QrV1oQGxXzk2atRsCI9gR0zKDJqFLqFJNYoecY07eI%3D&reserved=0)
The complete protocol is publically available on ClinicalTrials.gov (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fcdn.clinicaltrials.gov%2Flarge-docs%2F13%2FNCT03546413%2FProt_000.pdf&data=05%7C02%7Cfulham.rec%40hra.nhs.uk%7C1d552585d8c04944f6a908dd02fe9463%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638670014617987613%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=GRWoQpValpub0%2FjFqi4%2Fyo%2BN8vpUlXzamBlFnz2JsOM%3D&reserved=0) and included in the publication:
Protocol for: George Du Toit, Michelle F. Huffaker, Suzana Radulovic, et al. Follow-up to Adolescence after Early Peanut Introduction for Allergy Prevention. NEJM Evid. DOI: 10.1056/EVIDoa2300311 (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fevidence.nejm.org%2Fdoi%2Ffull%2F10.1056%2FEVIDoa2300311%23ap1&data=05%7C02%7Cfulham.rec%40hra.nhs.uk%7C1d552585d8c04944f6a908dd02fe9463%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638670014618010594%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=KnggR5aNVF7D0BT0x7spJe126J5cSbtukcVzG7JvNao%3D&reserved=0).The summary of study results for Protocol ITN070AD (LEAP Trio) are posted on ClinicalTrials.gov (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03546413%3Fterm%3DLEAP%2520TRio%26rank%3D1%26tab%3Dresults&data=05%7C02%7Cfulham.rec%40hra.nhs.uk%7C58c2a6a00a5242d937ae08de16266a47%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638972551410526293%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=M3uvctqg%2F%2BaWJMR%2Fs1%2BDcJ%2BB23PRFG0ArQfToIg839k%3D&reserved=0)
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/1609
Date of REC Opinion
28 Nov 2017
REC opinion
Further Information Favourable Opinion