Last updated: June 6, 2023
Sponsor: University of Southampton
Overall Status: Active - Recruiting
Phase
N/A
Condition
Allergy
Allergies & Asthma
Allergy (Pediatric)
Treatment
Peanut in common foods or supermarket-sourced cow's milk (CM)
Clinical Study ID
NCT05503446
ERGO 71012
IRAS ID 310316
Ages 3-23 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 6-23 years with IgE-mediated peanut allergy, or age 3-23 years with IgE-mediatedfood allergy to cow's milk
- Past history consistent with IgE-mediated allergy to the relevant allergen
- Allergic to cumulative ≤1.44 g protein (of the specific allergen) at baseline DBPCFC,prior to treatment allocation
- Written informed consent (for young people under 16, consent from the parent/legalguardian (AND assent from the young person when the young person is age 6+ years)
Exclusion
Exclusion Criteria:
- Required previous admission to an intensive care unit for management of an allergicreaction
- Clinically significant chronic illness (other than asthma, rhinitis or eczema)
- Moderate-severe eczema, defined as requiring more than once daily application of 1%hydrocortisone or equivalent topical calcineurin inhibitor as maintenance treatmentdespite appropriate use of emollients (eczema is not otherwise an exclusion criteria)
- Poorly controlled asthma within the previous 3 months (as defined by clinicianjudgement with reference to the International Consensus On (ICON) Pediatric Asthmaconsensus), or asthma requiring treatment with >5 days oral corticosteroids within theprevious 3 months
- Previous history of eosinophilic oesophagitis
- Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, and notyet established on maintenance dosing for at least 6 months
- Undergoing allergen immunotherapy for food allergy and within the first year oftreatment
- In CM-allergic children under consideration for desensitisation to CM:
- currently consuming CM-containing products other than extensively-heated milk inbaked foods (e.g. biscuits, cakes)
- significant symptoms of non-IgE-mediated CM allergy within the previous 12 months
- Taking prebiotic or probiotic supplements and unwillingness to discontinue
- Subjects receiving anti-IgE therapy, oral immunosuppressants, beta-blocker orAngiotensin Converting Enzyme (ACE) inhibitor
- Tolerance to cumulative ≥1.44 g food protein at initial DBPCFC during screening
- Objective allergic reaction to ≤4mg cow's milk protein or ½ Reese's puff inpeanut-allergic children, during screening
- Objective reaction to the placebo at screening DBPCFC
- Past or current medical issue, participation in another clinical trial or otherconsideration, which, in the opinion of the investigator, may pose additional risksfrom study participation, interfere with compliance or otherwise impact on the qualityor interpretation of study data
- Pregnancy
- Direct personal or commercial relationship with a member of the local study teamdirectly involved with the conduct of the trial
- Unwilling or unable to fulfil study requirements, including the requirement forappropriate supervision following dosing at home)
Study Design
Total Participants: 216
Treatment Group(s): 1
Primary Treatment: Peanut in common foods or supermarket-sourced cow's milk (CM)
Phase:
Study Start date:
January 19, 2023
Estimated Completion Date:
August 31, 2026
Connect with a study center
University of Hospitals of Leicester NHS Trust
Leicester,
United KingdomActive - Recruiting
Imperial College Healthcare NHS Trust
London,
United KingdomActive - Recruiting
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle,
United KingdomSite Not Available
Sheffield Children's Hospital NHS Foundation Trust
Sheffield,
United KingdomActive - Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton,
United KingdomActive - Recruiting
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