Peanut oral immunotherapy for sustained unresponsiveness in children

Induction of Sustained Unresponsiveness to Peanuts Using High- and Low-dose Peanut Oral Immunotherapy - Evaluation of Efficacy and Safety

This study is testing if giving children with peanut allergies a regular dose of peanut protein can help them safely eat peanuts again after avoiding them for a while.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 4 Years to 17 Years
• Sex: All
• Sponsor: Medical University of Warsaw (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Warsaw)
• Trial ID: NCT05163574 on ClinicalTrials.gov

What this trial studies

This study continues from a previous trial comparing the efficacy and safety of oral immunotherapy (OIT) using low and high doses of peanut protein in children with peanut allergies. Participants who completed the prior trial will receive the same maintenance dose of peanut allergen for at least 8 months, followed by a 4-week period of strict allergen avoidance. After this avoidance period, an open oral food challenge will be conducted to assess whether sustained unresponsiveness to peanuts has been achieved. The study aims to determine the long-term effectiveness of OIT in achieving lasting tolerance to peanut allergens.

Who should consider this trial

Good fit: Ideal candidates are children aged over 16 who have completed the previous trial and have a confirmed diagnosis of peanut allergy.

Not a fit: Patients with severe asthma, uncontrolled asthma, or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a long-term solution for children with peanut allergies, reducing the risk of allergic reactions.

How similar studies have performed: Previous studies on oral immunotherapy for food allergies have shown promising results, indicating that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* patients who have accomplished their per-protocol participation in trial NCT044155930.
* signed Informed Consent by parent/legal guardian and patient aged\>16 years old
* patient's/caregiver's cooperation with researcher

Exclusion Criteria:

* severe asthma
* uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)\<80% (under 5 percentile), FEV1/forced vital capacity (FEV)\<75% (under 5 percentile), hospitalization due to asthma exacerbation within last 12 months
* current oral/sublingual/subcutaneous immunotherapy with another allergen
* eosinophilic esophagitis
* allergic reaction of 4th or higher grade according to the World Allergy Organisation Systemic Allergic Reaction Grading System during immunotherapy
* a history of severe recurrent anaphylaxis episodes
* chronic diseases requiring continous treatment, including heart disease, epilepsy, metabolic disease, diabetes
* medication:

  * oral, daily steroid therapy exceeding 1 month within the last 12 months
  * at least two courses of oral steroid therapy (at least 7 days) within the last 12 months
  * oral steroid therapy longer than 7 days within the last 3 months
  * biological treatment
  * the need to constantly take antihistamines
  * therapy with b-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors
* pregnancy
* no consent to participate in the study
* lack of patient cooperation

Where this trial is running

Warsaw

• Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw — Warsaw, Poland (RECRUITING)

Study contacts

• Study coordinator: Magdalena Chojnowska-Wójtowicz, MD

Conditions: Peanut Allergy, peanut, food allergy, sustained unresponsiveness, children