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Using Commonly Available Food Products To Treat Food Allergy (NATASHA)

Primary Purpose

IgE-Mediated Cow Milk Allergy, Peanut Allergy

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Peanut in common foods or supermarket-sourced cow's milk (CM)

About this trial

This is an interventional treatment trial for IgE-Mediated Cow Milk Allergy

Eligibility Criteria

3 Years - 23 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 6-23 years with IgE-mediated peanut allergy, or age 3-23 years with IgE-mediated food allergy to cow's milk
Past history consistent with IgE-mediated allergy to the relevant allergen
Allergic to cumulative ≤1.44 g protein (of the specific allergen) at baseline DBPCFC, prior to treatment allocation
Written informed consent (for young people under 16, consent from the parent/legal guardian (AND assent from the young person when the young person is age 6+ years)

Exclusion Criteria:

Required previous admission to an intensive care unit for management of an allergic reaction
Clinically significant chronic illness (other than asthma, rhinitis or eczema)
Moderate-severe eczema, defined as requiring more than once daily application of 1% hydrocortisone or equivalent topical calcineurin inhibitor as maintenance treatment despite appropriate use of emollients (eczema is not otherwise an exclusion criteria)
Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the International Consensus On (ICON) Pediatric Asthma consensus), or asthma requiring treatment with >5 days oral corticosteroids within the previous 3 months
Previous history of eosinophilic oesophagitis
Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, and not yet established on maintenance dosing for at least 6 months
Undergoing allergen immunotherapy for food allergy and within the first year of treatment
In CM-allergic children under consideration for desensitisation to CM:
- currently consuming CM-containing products other than extensively-heated milk in baked foods (e.g. biscuits, cakes)
- significant symptoms of non-IgE-mediated CM allergy within the previous 12 months
Taking prebiotic or probiotic supplements and unwillingness to discontinue
Subjects receiving anti-IgE therapy, oral immunosuppressants, beta-blocker or Angiotensin Converting Enzyme (ACE) inhibitor
Tolerance to cumulative ≥1.44 g food protein at initial DBPCFC during screening
Objective allergic reaction to ≤4mg cow's milk protein or ½ Reese's puff in peanut-allergic children, during screening
Objective reaction to the placebo at screening DBPCFC
Past or current medical issue, participation in another clinical trial or other consideration, which, in the opinion of the investigator, may pose additional risks from study participation, interfere with compliance or otherwise impact on the quality or interpretation of study data
Pregnancy
Direct personal or commercial relationship with a member of the local study team directly involved with the conduct of the trial
Unwilling or unable to fulfil study requirements, including the requirement for appropriate supervision following dosing at home)

Sites / Locations

University of Hospitals of Leicester NHS TrustRecruiting
Imperial College Healthcare NHS TrustRecruiting
Newcastle upon Tyne Hospitals NHS Foundation Trust
Sheffield Children's Hospital NHS Foundation TrustRecruiting
University Hospital Southampton NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Oral Immunotherapy, in-hospital supervision for updosing

Oral Immunotherapy, virtual supervision for updosing

Control arm: allergen avoidance

Arm Description

Active oral immunotherapy, with all updosing visits taking place in hospital

Active oral immunotherapy, with all updosing visits taking place with virtual supervision

Outcomes

Primary Outcome Measures

Efficacy and effectiveness

The proportion of participants in intervention arms (combined) versus control arm (by allergen) who, following 9-12 months of OIT (or standard care, for controls): tolerate at least 1 gram of food protein (discrete dose, approximately 4-6 peanuts, or 30ml of CM) AND demonstrate a minimum 10-fold increase in the maximum tolerated dose (defined as the highest dose not causing dose-limiting symptoms) at the end-of-updosing double-blind, placebo-controlled food challenge (DBPCFC), compared to baseline DBPCFC

Secondary Outcome Measures

Safety: adverse events

i. Proportion of participants experiencing study-related adverse events (excluding mild, transient oropharyngeal symptoms) in active vs control arms, by allergen ii. Other safety outcomes: rate of anaphylaxis (and adrenaline [epinephrine] use), withdrawals due to intervention, by allergen iii. Adverse events (excluding mild, transient oropharyngeal symptoms) specifically occurring at updosing visits, in the home versus in-hospital updosing groups, by allergen

Health-related quality of life (HRQL) as assessed by the Food Allergy Quality of Life Questionnaire (FAQLQ)

Change in HRQL score assessed using validated questionnaire (Food Allergy Quality of Life Questionnaires (FAQLQ), from baseline at the following timepoints post allocation: 3, 6, end of induction (9-12 months), 18 and 24 months, in i. Participants ii. Parent/carers (if participants aged ≤17 years) The tools to be used are: - FAQLQ: as per Muraro et al, Allergy 2014; 69:845-853. A higher score is associated with a greater impact on quality of life, as per the cited reference.

Health-related quality of life (HRQL) as assessed by EQ5D

Change in quality of life assessment assessed using EQ5D, from baseline at the following timepoints post allocation: 3, 6, end of induction (9-12 months), 18 and 24 months, in i. Participants ii. Parent/carers (if participants aged ≤17 years) The tools to be used are: - EQ5D: a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys (see https://euroqol.org/ for detailed instructions on use)

Health-related quality of life (HRQL) as CHU9D

Change in quality of life assessment assessed using CHU9D, from baseline at the following timepoints post allocation: 3, 6, end of induction (9-12 months), 18 and 24 months, in i. Participants ii. Parent/carers (if participants aged ≤17 years) The tools to be used are: - CHU9D - a paediatric generic preference-based measure of health-related quality of life suitable for 7 to 17 year olds. (see https://licensing.sheffield.ac.uk/product/CHU-9D for detailed instructions on use)

Adherence to dietary avoidance

Adherence to dietary avoidance between intervention and control arms (by allergen, and between allergens) as determined by number of accidental reactions reported by each participant, during the duration of the study

Adherence to treatment

Adherence to daily OIT dosing by allergen, expressed as a the proportion of doses taken divided by the number of doses which should have been taken by each participant.

Immunological outcomes: change in skin prick test wheal

Change in immunological measures (skin prick test wheal (mm diameter) to commercial allergen extract, performed according to national guidelines) at baseline vs 12 months vs 24 months, between active and control arms (by allergen)

Immunological outcomes: change in allergen-specific serum antibody profile

Change in immunological measures (specific Immunoglobulin E (IgE) to specific allergen) measured by ImmunoCAP (kUA/l) at baseline vs 12 months vs 24 months, between active and control arms (by allergen)

Full Information

NCT ID

NCT05503446

First Posted

July 6, 2022

Last Updated

June 6, 2023

Sponsor

University of Southampton

Collaborators

Imperial College London, Natasha Allergy Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05503446

Brief Title

Using Commonly Available Food Products To Treat Food Allergy

Acronym

NATASHA

Official Title

Using Commonly Available Food Products To Treat Food Allergy (NATASHA Study)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 19, 2023 (Actual)

Primary Completion Date

August 31, 2025 (Anticipated)

Study Completion Date

August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Southampton

Collaborators

Imperial College London, Natasha Allergy Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Food allergy affects 1 in 30 children, and is the commonest trigger for life-threatening reactions (anaphylaxis) in this age group. It is a major public health issue, with practical implications for industry, education and healthcare systems. Oral immunotherapy (OIT) is an emerging treatment option, where small, increasing doses of a food allergen are used to cause "desensitisation", so food-allergic individuals no longer have symptoms when exposed to the trigger food. However, frequent allergic reactions during OIT (including anaphylaxis) are common, and can lead to patients having to stop treatment. In addition, food-allergic children usually dislike the taste of the food they are allergic too, which affects compliance and treatment success. There is a lack of longer-term data to inform cost-effectiveness analyses for OIT. The NATASHA study will recruit young people from age 6+ years with IgE-mediated peanut allergy, and young people aged 3+ years with IgE-mediated allergy to cow's milk, who will undergo oral immunotherapy for these allergens using real-world foods (taken carefully according to a standardised protocol under medical supervision). In addition to assessing efficacy and safety outcomes, we will also collect longer-term data to evaluate cost-effectiveness in the UK setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IgE-Mediated Cow Milk Allergy, Peanut Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel arm, with cross-over for those allocated to control group only following determination of primary outcome

Masking

Outcomes Assessor

Masking Description

Outcomes assessed by double-blind, placebo-controlled food challenge

Allocation

Randomized

Enrollment

216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral Immunotherapy, in-hospital supervision for updosing

Arm Type

Experimental

Arm Description

Active oral immunotherapy, with all updosing visits taking place in hospital

Arm Title

Oral Immunotherapy, virtual supervision for updosing

Arm Type

Experimental

Arm Description

Active oral immunotherapy, with all updosing visits taking place with virtual supervision

Arm Title

Control arm: allergen avoidance

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Peanut in common foods or supermarket-sourced cow's milk (CM)

Intervention Description

Participants will be given a set dose of peanut (e.g. peanut-containing cereal, whole peanuts) or cow's milk to take on a daily basis, as per protocol

Primary Outcome Measure Information:

Title

Efficacy and effectiveness

Description

Time Frame

9-12 months

Secondary Outcome Measure Information:

Title

Safety: adverse events

Description

Time Frame

24 months

Title

Health-related quality of life (HRQL) as assessed by the Food Allergy Quality of Life Questionnaire (FAQLQ)

Description

Time Frame

24 months

Title

Health-related quality of life (HRQL) as assessed by EQ5D

Description

Time Frame

24 months

Title

Health-related quality of life (HRQL) as CHU9D

Description

Time Frame

24 months

Title

Adherence to dietary avoidance

Description

Time Frame

24 months

Title

Adherence to treatment

Description

Adherence to daily OIT dosing by allergen, expressed as a the proportion of doses taken divided by the number of doses which should have been taken by each participant.

Time Frame

24 months

Title

Immunological outcomes: change in skin prick test wheal

Description

Time Frame

24 months

Title

Immunological outcomes: change in allergen-specific serum antibody profile

Description

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

23 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 6-23 years with IgE-mediated peanut allergy, or age 3-23 years with IgE-mediated food allergy to cow's milk Past history consistent with IgE-mediated allergy to the relevant allergen Allergic to cumulative ≤1.44 g protein (of the specific allergen) at baseline DBPCFC, prior to treatment allocation Written informed consent (for young people under 16, consent from the parent/legal guardian (AND assent from the young person when the young person is age 6+ years) Exclusion Criteria: Required previous admission to an intensive care unit for management of an allergic reaction Clinically significant chronic illness (other than asthma, rhinitis or eczema) Moderate-severe eczema, defined as requiring more than once daily application of 1% hydrocortisone or equivalent topical calcineurin inhibitor as maintenance treatment despite appropriate use of emollients (eczema is not otherwise an exclusion criteria) Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the International Consensus On (ICON) Pediatric Asthma consensus), or asthma requiring treatment with >5 days oral corticosteroids within the previous 3 months Previous history of eosinophilic oesophagitis Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, and not yet established on maintenance dosing for at least 6 months Undergoing allergen immunotherapy for food allergy and within the first year of treatment In CM-allergic children under consideration for desensitisation to CM: currently consuming CM-containing products other than extensively-heated milk in baked foods (e.g. biscuits, cakes) significant symptoms of non-IgE-mediated CM allergy within the previous 12 months Taking prebiotic or probiotic supplements and unwillingness to discontinue Subjects receiving anti-IgE therapy, oral immunosuppressants, beta-blocker or Angiotensin Converting Enzyme (ACE) inhibitor Tolerance to cumulative ≥1.44 g food protein at initial DBPCFC during screening Objective allergic reaction to ≤4mg cow's milk protein or ½ Reese's puff in peanut-allergic children, during screening Objective reaction to the placebo at screening DBPCFC Past or current medical issue, participation in another clinical trial or other consideration, which, in the opinion of the investigator, may pose additional risks from study participation, interfere with compliance or otherwise impact on the quality or interpretation of study data Pregnancy Direct personal or commercial relationship with a member of the local study team directly involved with the conduct of the trial Unwilling or unable to fulfil study requirements, including the requirement for appropriate supervision following dosing at home)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hasan Arshad, MBBS DM FRCP

Phone

44 23 8120 5232

p.turner@imperial.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul J Turner, FRCPCH PhD

Organizational Affiliation

Imperial College London

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Hospitals of Leicester NHS Trust

City

Leicester

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Imperial College Healthcare NHS Trust

City

London

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Newcastle upon Tyne Hospitals NHS Foundation Trust

City

Newcastle

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Name

Sheffield Children's Hospital NHS Foundation Trust

City

Sheffield

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

University Hospital Southampton NHS Foundation Trust

City

Southampton

Country

United Kingdom

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Deidentified data may be available upon request to the Chief Investigators, subject to local data protection legislation.

Learn more about this trial

Using Commonly Available Food Products To Treat Food Allergy

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