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

Study Purpose

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.#46;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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05407012
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	King's College London
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Carsten Flohr
Principal Investigator Affiliation	King's College London
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Allergy;Food, Food Allergy Peanut, Pathways and Sources of Exposure

Additional Details

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.

Arms & Interventions

Arms

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.

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.

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;

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Stuart Jones

stuart.jones@kcl.ac.uk

0207 848 4506

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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