Dietary changes to support immune health in children with peanut and nut allergies

Effect of an Immune-supportive Diet on Gut Permeability and Allergic Symptoms in Children With Peanut and/or Nut Allergy

This study is testing if a special diet can help children with peanut and nut allergies feel better by improving their gut health and reducing allergic reactions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 3 Years to 17 Years
• Sex: All
• Sponsor: Onze Lieve Vrouwe Gasthuis (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Amsterdam)
• Trial ID: NCT05667610 on ClinicalTrials.gov

What this trial studies

This study investigates the relationship between gut permeability and threshold levels for peanut and nut allergies in children. It aims to determine how an immune-supportive diet may restore gut permeability and alleviate allergic symptoms. The study will include children aged 3 to 17 who have a confirmed allergy to peanuts or nuts, and will assess their reactions to these allergens through controlled challenges. The research seeks to provide insights into the underlying mechanisms of allergic reactions and the potential role of diet in managing these conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 3 to 17 with confirmed peanut or nut allergies and specific IgE levels.

Not a fit: Patients with only mild oral symptoms due to pollen food syndrome or those with gastrointestinal diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to dietary recommendations that help reduce allergic reactions in children with peanut and nut allergies.

How similar studies have performed: While dietary interventions have been explored in allergy management, this specific approach focusing on gut permeability and immune support is relatively novel.

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 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.

Where this trial is running

Amsterdam

• OLVG — Amsterdam, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Berber Vlieg-Boerstra

Conditions: Peanut Allergy, Nut Allergy, Gut permeability, Immune-supportive diet, Thresholds