About this trial
Peanut and nut allergy can be life threatening. Some patients have very low threshold levels (i.e. the amounts of peanut and nuts to which the patients react), others react to higher doses. The reasons for these differences in threshold are not well understood. Patients with peanut and nut allergy often suffer from other allergic diseases (atopic dermatitis, hay fever and asthma). A disturbed gut microbiota composition and an increased gut permeability may explain the development of allergic disease. We hypothesize that increased gut permeability is related to low threshold levels to peanuts or nuts. In addition, as it is known that nutrition can influence our gut permeability, we also hypothesize that a healthful immune-supportive diet restores gut permeability and alleviates symptoms.
Therefore, the purpose of the study is to study in peanut and nut allergic children:
1. the relationship between gut permeability and threshold levels to peanut or nuts; 2. the effect of an immune-supportive diet on gut permeability, gut microbiome composition, coexisting allergic symptoms and quality of life
Eligibility criteria
Qualifiers
Children of 3 to 17 years of age with a positive open or double-blind placebo-controlled peanut or nut challenge < 12 months to inclusion OR an obvious and objective IgE-mediated allergic reaction following the consumption of isolated peanut or nut within 1 hours, confirmed by sensitisation to peanut or nut < 24 months to inclusion;
Children who are potty trained or house trained;
Presence of IgE to peanut ≥0.35 kilo units per liter (kU/l) or skin prick test > 3 mm to peanut or nut, < 12 months prior to challenge.
Disqualifiers
Only mild symptoms in the oral cavity to peanut or nut due to pollen food syndrome;
A negative peanut or nut challenge;
Children who are not potty trained (house trained);
Gastro-intestinal diseases (e.g. Morbus Crohn, coeliac disease, Colitis Ulcerosa), lactose intolerance
Trial design
Treatments tested in this trial
- Immune-supportive diet
- Standard care
Treatment groups
Sponsors and collaborators
Onze Lieve Vrouwe Gasthuis
Lead sponsor
Ekhaga foundation
Collaborator
Rijnstate Hospital
Collaborator
Noordwest Ziekenhuisgroep
Collaborator
Erasmus Medical Center
Collaborator
Wageningen University
Collaborator
Amsterdam UMC
Collaborator
Utrecht Institute for Pharmaceutical Sciences
Collaborator
Diakonessenhuis, Utrecht
Collaborator
Deventer Ziekenhuis
Collaborator
Harvard University
Collaborator