Phase
Condition
Allergy
Allergies & Asthma
Allergy (Peanut)
Treatment
Peanut in common foods or supermarket-sourced cow's milk (CM)
Clinical Study ID
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 baselineDBPCFC, 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 exclusioncriteria)
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 withinthe previous 3 months
Previous history of eosinophilic oesophagitis
Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, andnot yet 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 milkin baked foods (e.g. biscuits, cakes)
significant symptoms of non-IgE-mediated CM allergy within the previous 12months
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 thequality or 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
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

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.