Actively Recruiting

Phase Not Applicable
Age: 3Years - 17Years
All Genders
Healthy Volunteers
NCT05667610

Immune-supportive Diet and Gut Permeability in Allergic Children

Led by Onze Lieve Vrouwe Gasthuis · Updated on 2025-05-01

132

Participants Needed

1

Research Sites

250 weeks

Total Duration

On this page

Sponsors

O

Onze Lieve Vrouwe Gasthuis

Lead Sponsor

E

Ekhaga foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Immune-supportive Diet and Gut Permeability in Allergic Children

Who Can Participate

Age: 3Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 17 years with a positive peanut or nut allergy challenge within 12 months or a clear IgE-mediated allergic reaction within 1 hour confirmed by sensitization within 24 months
  • Children who are potty trained or house trained
  • Presence of IgE to peanut ≥0.35 kU/l or positive skin prick test >3 mm to peanut or nut within 12 months prior to challenge
Not Eligible

You will not qualify if you...

  • Only mild oral symptoms to peanut or nut due to pollen food syndrome
  • Negative peanut or nut challenge
  • Children who are not potty trained or house trained
  • Gastrointestinal diseases such as Crohn's disease, celiac disease, or ulcerative colitis, and lactose intolerance
  • Severe cow's milk allergy
  • Syndromes, infectious or immunological diseases other than atopy, or diabetes
  • Use of laxative treatment such as lactulose
  • Unable to read or write Dutch

AI-Screening

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Trial Site Locations

Total: 1 location

1

OLVG

Amsterdam, Netherlands

Actively Recruiting

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Research Team

B

Berber Vlieg-Boerstra

CONTACT

C

Chantal den Elzen, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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