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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Allergy;Food; Food Allergy Peanut; Pathways and Sources of Exposure
• Intervention / Treatment: Other: Application of the barrier enhancing preparation.

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stuart Jones; Phone Number: 0207 848 4506; Email: stuart.jones@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention of the barrier enhancing preparation; Dry skin or atopic dermatitis or healthy skin; application of the peanut protein extract +/- massage after extract application.	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;
No Intervention: Absence of the barrier enhancing preparation; Dry skin or atopic dermatitis or healthy skin; application of the peanut protein extract +/- massage after extract application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks
Raised transepidermal water loss.	Raised transepidermal water loss.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess skin barrier function measures (skin surface pH).	Assess skin barrier function measures (skin surface pH).	8 weeks

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Charite University, Berlin, Germany; University Hospital, Bonn; Institut Curie; Levantine UK
• Investigators: Principal Investigator: Carsten Flohr, King's College London

Study record dates

Study Major Dates

• Study Start (Estimated): November 13, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Allergy; Dermatology; Food safety; Public health; Food manufacture
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: RE19787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No