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Can a daily peanut dose help kids tolerate peanuts?

NCT ID NCT04415593

Disease control Sponsor: Medical University of Warsaw Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving children with peanut allergy a daily dose of peanut protein (either 150 mg or 300 mg) could help them tolerate more peanuts over time. 44 children participated, and researchers measured how much peanut protein they could safely eat after treatment. The goal was to find the best dose that balances effectiveness and safety.

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

44 people

The number who actually took part.

Started

Sep 2020

Finished

Jul 2024

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

4 to 17 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: * medical history of peanut allergy, * IgE-mediated peanut allergy confirmed as positive skin prick tests with peanut allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35 kilo units of Allergen per liter (kUA/l) (UniCAP method), * reaction to less than 100 mg of peanut protein during OOFC, * signed Informed Consent by parent/legal guardian and patient aged \>16 years old, * patient's/caregivers' cooperation with researcher. Exclusion Criteria: * no confirmed peanut allergy, * negative oral food challenge with less than 100mg of peanut protein, * severe asthma, * uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)\<80% (under 5. percentile), FEV1/forced vital capacity (FVC)\<75% (under 5. percentile), hospitalization due to asthma exacerbation within last 12 months, * current oral/sublingual/subcutaneous immunotherapy with other allergen, * eosinophilic gastroenteritis, * a history of severe recurrent anaphylaxis episodes, * chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes, * medication: * oral, daily steroid therapy longer than 1 month within last 12 months, * at least two courses of oral steroid therapy (at least 7 days) within last 12 months, * oral steroid therapy longer than 7 days within last 3 months, * biological treatment, * the need to constantly take antihistamines, * therapy with β-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors, * pregnancy, * no consent to participate in the study, * lack of patient cooperation.

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Conditions

The condition(s) this trial relates to.

food allergy Peanut Hypersensitivity

As listed by the trial registrant

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

Peanut allergy

Contacts and locations

Locations

  • Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw

    Warsaw, 02-091, Poland

More trials for these conditions

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