Immune-supportive Diet and Gut Permeability in Allergic Children

NCT05667610 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-05-01

No results posted yet for this study

Summary

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

Interventions

OTHER

Immune-supportive diet

The intervention includes a immune-supportive diet over a period of 4 months

OTHER

Standard care

Standard care: Peanut or nut free diet

Sponsors & Collaborators

  • Ekhaga foundation

    collaborator UNKNOWN
  • Rijnstate Hospital

    collaborator OTHER
  • Noordwest Ziekenhuisgroep

    collaborator OTHER
  • Erasmus Medical Center

    collaborator OTHER
  • Wageningen University

    collaborator OTHER
  • Amsterdam UMC

    collaborator OTHER
  • Utrecht Institute for Pharmaceutical Sciences

    collaborator OTHER
  • Diakonessenhuis, Utrecht

    collaborator OTHER
  • Deventer Ziekenhuis

    collaborator OTHER
  • Harvard University

    collaborator OTHER
  • Onze Lieve Vrouwe Gasthuis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05667610 on ClinicalTrials.gov