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TRANS-FOODS: Preventing Peanut Allergy Through Improved Understanding of the Transcutaneous Sensitisation Route, Novel Food Processing and Skin Care Adaptations

NCT05407012 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-05-06

No results posted yet for this study

Summary

This project aims to study the immune responses to peanut allergen in those with a skin barrier defect with and without skin massage, specifically it aims to:

1. Establish if peanut allergen components can pass into human skin through regular massage using the peanut protein-containing extract.
2. Clarify whether this effect is amplified in those with an impaired skin barrier (AD and dry skin vs healthy controls).
3. Assess whether peanut protein components can be detected in interstitial skin fluid (ISF) using a suction device.
4. Test whether peanut protein components present in ISF are able to induce activation of basophils in blood of peanut allergic donors.
5. Assess whether the transcutaneous uptake of peanut protein can be reduced by the prior use of a barrier enhancing cream.

Conditions

  • Allergy;Food
  • Food Allergy Peanut
  • Pathways and Sources of Exposure

Interventions

OTHER

Application of the barrier enhancing preparation.

Application of the barrier enhancing preparation around 30 minutes before application of the peanut protein extract +/- massage after extract application;

Sponsors & Collaborators

  • University Hospital, Bonn

    collaborator OTHER

  • Institut Curie

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Levantine UK

    collaborator UNKNOWN

  • King's College London

    lead OTHER

Principal Investigators

  • Carsten Flohr · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-05
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

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 NCT05407012 on ClinicalTrials.gov