Immune-supportive Diet and Gut Permeability in Allergic Children
Recruiting
N/AInterventional Study
Peanut AllergyNut Allergy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
3 – 17
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
132 (estimated)
Sponsor
Onze Lieve Vrouwe Gasthuis · Other
Who this trial is looking for
This trial is looking for children aged 3 to 17 who have a peanut or nut allergy. Participants will explore how diet affects gut health and allergy symptoms.
Are You a Good Fit for This Trial?
Rules you outGastrointestinal diseasesSevere cow's milk allergy
You may be able to join if
I am between 3 and 17 years old.
I have a peanut or nut allergy confirmed by a recent test.
I have experienced an allergic reaction after eating peanuts or nuts.
I am potty trained.
I have a specific level of IgE to peanuts.
You may not be able to join if
I only have mild symptoms in my mouth from food allergies.
I have had a negative peanut or nut allergy test.
I am not potty trained.
I have gastrointestinal diseases like Crohn's or celiac disease.
I have severe cow's milk allergy.
I am taking laxatives.
I cannot read or write Dutch.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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
Trial Locations
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Eligibility Criteria
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 b…
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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