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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Application of the barrier enhancing preparation.
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Allergy;Food focused on measuring Allergy, Food safety, Public health, Dermatology, Food manufacture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult healthy volunteers (50% of the cohort), and adults with dry skin and AD (fulfilling the refined Hanifin and Rajka criteria, 50% of the cohort).
  • Willingness to apply the study intervention and to not use any other topical preparations over theforearms during the study period.

Exclusion Criteria:

  • History of peanut allergy.
  • Positive skin prick test to peanut (>0 mm).
  • No regular consumption of peanut products.
  • Widespread AD, in particular if this involves the test sites of the forearms.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention of the barrier enhancing preparation

    Absence of the barrier enhancing preparation

    Arm Description

    Dry skin or atopic dermatitis or healthy skin; application of the peanut protein extract +/- massage after extract application.

    Dry skin or atopic dermatitis or healthy skin; application of the peanut protein extract +/- massage after extract application.

    Outcomes

    Primary Outcome Measures

    Detection of peanut protein components (μg of the proteins per cm² of skin) in retrieved interstitial fluid.
    Detection of peanut protein components (μg of the proteins per cm² of skin) in retrieved interstitial fluid.
    Activation of blood basophil from peanut allergic donors (measured as %CD63-positive basophils) by peanut proteins present in interstitial fluid.
    Activation of blood basophil from peanut allergic donors (measured as %CD63-positive basophils) by peanut proteins present in interstitial fluid.

    Secondary Outcome Measures

    Detection of inflammatory cytokine markers (IL-4, IL-13, IL-33 and TSLP) in interstitial fluid.
    Detection of inflammatory cytokine markers (IL-4, IL-13, IL-33 and TSLP) in interstitial fluid.
    Raised transepidermal water loss.
    Raised transepidermal water loss.

    Full Information

    First Posted
    May 26, 2022
    Last Updated
    October 11, 2023
    Sponsor
    King's College London
    Collaborators
    University Hospital, Bonn, Institut Curie, Charite University, Berlin, Germany, Levantine UK
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05407012
    Brief Title
    TRANS-FOODS: Preventing Peanut Allergy Through Improved Understanding of the Transcutaneous Sensitisation Route, Novel Food Processing and Skin Care Adaptations
    Acronym
    TRANS-FOODS
    Official Title
    TRANS-FOODS: Preventing Peanut Allergy Through Improved Understanding of the Transcutaneous Sensitisation Route, Novel Food Processing and Skin Care Adaptations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 13, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2025 (Anticipated)
    Study Completion Date
    May 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    King's College London
    Collaborators
    University Hospital, Bonn, Institut Curie, Charite University, Berlin, Germany, Levantine UK

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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: Establish if peanut allergen components can pass into human skin through regular massage using the peanut protein-containing extract. Clarify whether this effect is amplified in those with an impaired skin barrier (AD and dry skin vs healthy controls). Assess whether peanut protein components can be detected in interstitial skin fluid (ISF) using a suction device. Test whether peanut protein components present in ISF are able to induce activation of basophils in blood of peanut allergic donors. Assess whether the transcutaneous uptake of peanut protein can be reduced by the prior use of a barrier enhancing cream.
    Detailed Description
    The study aims to understand how peanut processing methods and peanut co-administration with oils, as is standard during the industrial processing of peanuts, influences the development of peanut allergy through the skin. Cutaneous exposure of allergens is a crucial, but hitherto under explored route of food sensitisation, that if understood could lead to the development of translatable strategies to prevent food allergy. Food processors require a greater understanding of how allergen exposure cause allergy so that they can adapt their processing methods to counteract these exposure processes. Furthermore, this proposed research aligns with on-going efforts across Europe to address the increasing problems associated with food allergy but it is unique in that it focuses on cutaneous allergen exposure, which is a field in desperate need of more systematic study. The assembled team of investigators (from the UK, Germany and France) joined by a peanut industry partner (Levantine) and patient and consumer representatives will aim to address the following hypotheses: Understanding the mechanisms by which: Peanut proteins pass into the skin via the appendages to trigger an immune response. Skin stretching that occurs during massage opens up the skin appendages allowing more peanut protein into the skin and leads to dendritic cell activation and induction of T helper 2 cell response. Co-administration of peanut proteins and an oil to the skin increases allergenicity. Skin barrier impairment and inflammation (AD) increases allergenicity. Test novel approaches to peanut allergy prevention whereby: Modifications in peanut processing can reduce allergen exposure via the skin. Meticulous hand hygiene reduces skin contamination with peanut protein. Application of a barrier enhancing cream can strengthen the skin barrier, in particular in those with atopic dermatitis, and reduce the risk of transcutaneous sensitisation further.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergy;Food, Food Allergy Peanut, Pathways and Sources of Exposure
    Keywords
    Allergy, Food safety, Public health, Dermatology, Food manufacture

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention of the barrier enhancing preparation
    Arm Type
    Experimental
    Arm Description
    Dry skin or atopic dermatitis or healthy skin; application of the peanut protein extract +/- massage after extract application.
    Arm Title
    Absence of the barrier enhancing preparation
    Arm Type
    No Intervention
    Arm Description
    Dry skin or atopic dermatitis or healthy skin; application of the peanut protein extract +/- massage after extract application.
    Intervention Type
    Other
    Intervention Name(s)
    Application of the barrier enhancing preparation.
    Intervention Description
    Application of the barrier enhancing preparation around 30 minutes before application of the peanut protein extract +/- massage after extract application;
    Primary Outcome Measure Information:
    Title
    Detection of peanut protein components (μg of the proteins per cm² of skin) in retrieved interstitial fluid.
    Description
    Detection of peanut protein components (μg of the proteins per cm² of skin) in retrieved interstitial fluid.
    Time Frame
    8 weeks
    Title
    Activation of blood basophil from peanut allergic donors (measured as %CD63-positive basophils) by peanut proteins present in interstitial fluid.
    Description
    Activation of blood basophil from peanut allergic donors (measured as %CD63-positive basophils) by peanut proteins present in interstitial fluid.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Detection of inflammatory cytokine markers (IL-4, IL-13, IL-33 and TSLP) in interstitial fluid.
    Description
    Detection of inflammatory cytokine markers (IL-4, IL-13, IL-33 and TSLP) in interstitial fluid.
    Time Frame
    8 weeks
    Title
    Raised transepidermal water loss.
    Description
    Raised transepidermal water loss.
    Time Frame
    8 weeks
    Other Pre-specified Outcome Measures:
    Title
    Assess skin barrier function measures (skin surface pH).
    Description
    Assess skin barrier function measures (skin surface pH).
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult healthy volunteers (50% of the cohort), and adults with dry skin and AD (fulfilling the refined Hanifin and Rajka criteria, 50% of the cohort). Willingness to apply the study intervention and to not use any other topical preparations over theforearms during the study period. Exclusion Criteria: History of peanut allergy. Positive skin prick test to peanut (>0 mm). No regular consumption of peanut products. Widespread AD, in particular if this involves the test sites of the forearms.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stuart Jones
    Phone
    0207 848 4506
    Email
    stuart.jones@kcl.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carsten Flohr
    Organizational Affiliation
    King's College London
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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