Actively Recruiting

Phase Not Applicable
Age: 3Years - 17Years
All Genders
Healthy Volunteers
ID05667610

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

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

132

Participants Needed

1

Research Sites

52 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

Researchers are studying peanut and nut allergy in children aged 3 to 17 years to understand why there are differences in how sensitive children are to peanuts and nuts. The study focuses on the relationship between gut permeability, which is how easily substances pass through the gut lining, and the threshold levels that trigger allergic reactions. It also examines how an immune-supportive diet might improve gut health, reduce allergic symptoms, and enhance quality of life in these children. Peanut and nut allergies often occur alongside other allergic conditions like asthma and eczema, which are linked to inflammation and immune responses. The study compares two groups of children: one group follows an immune-supportive diet for 4 months alongside a peanut and nut-free diet, while the other group follows only the peanut and nut-free diet. The immune-supportive diet categorizes foods into three groups based on their effects on immune health, recommending some foods in ample amounts, others in limited amounts, and advising against certain foods. Researchers will monitor adherence to the diet through food diaries and self-assessments during and after the intervention. Participants will undergo various assessments including tests for small intestine permeability using urine samples, evaluations of allergic symptoms such as atopic dermatitis and asthma, and measurements of gut microbiota composition. These evaluations occur at the start and after 4 months of dietary intervention. Researchers will also assess quality of life, medication use, respiratory infections, and dietary adherence throughout the study. The primary outcome is the change in gut permeability after the dietary intervention, helping to clarify how diet may impact allergic responses in children with peanut and nut allergies.

CONDITIONS

Brief 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
  • Confirmed peanut or nut allergy by positive food challenge within 12 months or clear allergic reaction within 1 hour confirmed by sensitization within 24 months
  • Potty trained or house trained
  • Presence of IgE to peanut ≥0.35 kU/l or skin prick test >3 mm to peanut or nut within 12 months before challenge
Not Eligible

You will not qualify if you...

  • Only mild symptoms in the mouth due to pollen food syndrome
  • Negative peanut or nut challenge
  • Not potty trained or house trained
  • Gastrointestinal diseases such as Crohn's disease, celiac disease, colitis ulcerosa, or lactose intolerance
  • Severe cow's milk allergy
  • Syndromes, infectious or immunological diseases other than atopy, or diabetes
  • Use of laxative treatment such as lactulose
  • Inability to read or write Dutch

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 months

Participants follow either an immune-supportive diet or a standard peanut and/or nut free diet for 4 months to study the effects on gut permeability and allergic symptoms.

Visits for assessments at baseline, 2.5 months, and 4 months

Follow-up

Duration - Short-term post-treatment assessment period

After the dietary intervention, participants' gut permeability, allergic symptoms, and dietary adherence are assessed to evaluate the effects of the intervention.

Visits at 4 months including final assessments

Trial Site Locations

Total: 1 location

1

OLVG

Amsterdam, Netherlands

Actively Recruiting

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Research Team

B

Berber Vlieg-Boerstra

C

Chantal den Elzen, MSc

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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