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
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
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
NCT ID
NCT05407012
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
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
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TRANS-FOODS: Preventing Peanut Allergy Through Improved Understanding of the Transcutaneous Sensitisation Route, Novel Food Processing and Skin Care Adaptations
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