IgE-Mediated Cow Milk AllergyNATASHANCT05503446
Using Commonly Available Food Products To Treat Food Allergy
A study testing Peanut in common foods or supermarket-sourced cow's milk (CM) in people with IgE-Mediated Cow Milk Allergy and Peanut Allergy, run by University of Southampton at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 23 years
- Conditions the study is for
- IgE-Mediated Cow Milk Allergy, Peanut Allergy
- What is being tested?
- Peanut in common foods or supermarket-sourced cow's milk (CM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 19 Jan 2023to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
University of Hospitals of Leicester NHS Trust
Leicester
Imperial College Healthcare NHS Trust
London
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle
Sheffield Children's Hospital NHS Foundation Trust
Sheffield
University Hospital Southampton NHS Foundation Trust
Southampton
About this study
Official title: Using Commonly Available Food Products To Treat Food Allergy (NATASHA Study)
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.
- Conditions
- IgE-Mediated Cow Milk Allergy, Peanut Allergy
- Being tested
- Peanut in common foods or supermarket-sourced cow's milk (CM)
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut in common foods or supermarket-sourced cow's milk (CM)Other
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
| Study group | Role | What they receive |
|---|---|---|
| Oral Immunotherapy, in-hospital supervision for updosing | Experimental | Active oral immunotherapy, with all updosing visits taking place in hospital Receives: Other: Peanut in common foods or supermarket-sourced cow's milk (CM) |
| Oral Immunotherapy, virtual supervision for updosing | Experimental | Active oral immunotherapy, with all updosing visits taking place with virtual supervision Receives: Other: Peanut in common foods or supermarket-sourced cow's milk (CM) |
| Control arm: allergen avoidance | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9-12 months
Secondary outcomes (8)
Safety: adverse events
- 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
Measured: 24 months
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.
Measured: 24 months
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)
Measured: 24 months
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)
Measured: 24 months
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
Measured: 24 months
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.
Measured: 24 months
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)
Measured: 24 months
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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start19 Jan 2023
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgE-Mediated Cow Milk AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel arm, with cross-over for those allocated to control group only following determination of primary outcome
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Natasha Allergy Research Foundation
- Responsible party
- Sponsor
- Investigators
- Paul J Turner, FRCPCH PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503446
- Sponsor's protocol ID
- ERGO 71012
- Other IDs
- IRAS ID 310316
- Acronym
- NATASHA
- Status last verified
- Jun 2025
- First submitted
- 6 Jul 2022
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data may be available upon request to the Chief Investigators, subject to local data protection legislation.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Commonly Available Food Products To Treat Food Allergy (NATASHA Study)
- ClinicalTrials.gov ID
- NCT05503446
- Acronym / sponsor ID
- NATASHA / ERGO 71012
- Conditions
- IgE-Mediated Cow Milk Allergy, Peanut Allergy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Imperial College London, Natasha Allergy Research Foundation
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel arm, with cross-over for those allocated to control group only following determination of primary outcome
| Arm | Type | Receives |
|---|---|---|
| Oral Immunotherapy, in-hospital supervision for updosing | Experimental | Other: Peanut in common foods or supermarket-sourced cow's milk (CM)Active oral immunotherapy, with all updosing visits taking place in hospital |
| Oral Immunotherapy, virtual supervision for updosing | Experimental | Other: Peanut in common foods or supermarket-sourced cow's milk (CM)Active oral immunotherapy, with all updosing visits taking place with virtual supervision |
| Control arm: allergen avoidance | No intervention | – |
Who may qualify
- Ages
- 3 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut in common foods or supermarket-sourced cow's milk (CM)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 | Other | Oral Immunotherapy, in-hospital supervision for updosing, Oral Immunotherapy, virtual supervision for updosing |
Primary outcome
Efficacy and effectiveness
Time frame: 9-12 months
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
8 secondary outcomes
Safety: adverse events
Time frame: 24 months
Health-related quality of life (HRQL) as assessed by the Food Allergy Quality of Life Questionnaire (FAQLQ)
Time frame: 24 months
Health-related quality of life (HRQL) as assessed by EQ5D
Time frame: 24 months
Health-related quality of life (HRQL) as CHU9D
Time frame: 24 months
Adherence to dietary avoidance
Time frame: 24 months
Adherence to treatment
Time frame: 24 months
Immunological outcomes: change in skin prick test wheal
Time frame: 24 months
Immunological outcomes: change in allergen-specific serum antibody profile
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. Deidentified data may be available upon request to the Chief Investigators, subject to local data protection legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Turner, FRCPCH PhD principal investigator
Imperial College London
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut in common foods or supermarket-sourced cow's milk (CM) in people with IgE-Mediated Cow Milk Allergy and Peanut Allergy, run by University of Southampton at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and effectiveness (time frame: 9-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.