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Immune-supportive Diet and Gut Permeability in Allergic Children

RecruitingNAAges 3 Years - 17 YearsAllOnze Lieve Vrouwe Gasthuis
NCT05667610 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 relation

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. 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), lactose intolerance * severe cow's milk allergy -because of possible traces of cow's milk in lactose in the SAT), syndromes, infectious/immunology diseases other than atopy, or diabetes; * Laxative treatment, such as lactulose; * Not able to read or write Dutch.
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What it tests

  • Immune-supportive diet
  • Standard care
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Where

1 site
OLVG
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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