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Could supermarket peanuts and milk cure food allergies? new study investigates.

NCT ID NCT05503446

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether giving children small daily doses of peanut or cow's milk from common foods (like cereal or whole peanuts) can help them tolerate these allergens. It involves 216 children aged 3-23 with peanut or cow's milk allergy. The goal is to see if this simple approach can safely reduce allergic reactions and improve quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Peanut or cow's milk from common foods (e.g., peanut cereal, whole peanuts, supermarket milk)
What this could lead to
If successful, this could offer a practical, low-cost way to help children with peanut or milk allergies eat these foods without severe reactions.
What could go wrong
This is an early-stage study with 216 participants, and allergic reactions (including anaphylaxis) are common during oral immunotherapy. Results may not apply to all patients or allergens.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 23 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 6-23 years with IgE-mediated peanut allergy, or age 3-23 years with IgE-mediated food allergy to cow's milk 2. Past history consistent with IgE-mediated allergy to the relevant allergen 3. Allergic to cumulative ≤1.44 g protein (of the specific allergen) at baseline DBPCFC, prior to treatment allocation 4. 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: 1. Required previous admission to an intensive care unit for management of an allergic reaction 2. Clinically significant chronic illness (other than asthma, rhinitis or eczema) 3. 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) 4. 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 5. Previous history of eosinophilic oesophagitis 6. Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, and not yet established on maintenance dosing for at least 6 months 7. Undergoing allergen immunotherapy for food allergy and within the first year of treatment 8. 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 9. Taking prebiotic or probiotic supplements and unwillingness to discontinue 10. Subjects receiving anti-IgE therapy, oral immunosuppressants, beta-blocker or Angiotensin Converting Enzyme (ACE) inhibitor 11. Tolerance to cumulative ≥1.44 g food protein at initial DBPCFC during screening 12. Objective allergic reaction to ≤4mg cow's milk protein or ½ Reese's puff in peanut-allergic children, during screening 13. Objective reaction to the placebo at screening DBPCFC 14. 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 15. Pregnancy 16. Direct personal or commercial relationship with a member of the local study team directly involved with the conduct of the trial 17. Unwilling or unable to fulfil study requirements, including the requirement for appropriate supervision following dosing at home)

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Conditions

The condition(s) this trial relates to.

food allergy Heiner syndrome Peanut Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Imperial College Healthcare NHS Trust

    London, United Kingdom

  • Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle, United Kingdom

  • Sheffield Children's Hospital NHS Foundation Trust

    Sheffield, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    Southampton, United Kingdom

  • University of Hospitals of Leicester NHS Trust

    Leicester, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.