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NCT05667610
Immune-supportive Diet and Gut Permeability in Allergic Children
Conditions: Peanut Allergy, Nut Allergy
Sex: All
Ages: 4 Years – 12 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 132
Sponsor: Onze Lieve Vrouwe Gasthuis
Location: Netherlands
Summary
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:the relationship between gut permeability and threshold levels to peanut or nuts;the effect of an immune-supportive diet on gut permeability, gut microbiome composition, coexisting allergic symptoms and quality of life
Eligibility Criteria
Inclusion Criteria:Children of 4 to 12 years of age with a positive open or double-blind placebo-controlled peanut or nut challenge < 12 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.Exclusion Criteria: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), syndromes, infectious/immunology diseases other than atopy, or diabetes;Laxative treatment, such as lactulose;Not able to read or write Dutch.
Source: ClinicalTrials.gov (NCT05667610). StuddyBuddy aggregates publicly available trial information.