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

Not Applicable

Recruiting

• Conditions: Peanut Allergy
• Interventions: Dietary Supplement: Low dose OIT; Dietary Supplement: High dose OIT

• Registration Number: NCT05163574
• Lead Sponsor: Medical University of Warsaw

Brief Summary

This study is a continuation of a clinical trial NCT044155930 comparing the efficacy and safety of oral immunotherapy (OIT) with low or high doses of peanut protein (150 or 300 mg, respectively) and will involve patients who have accomplished their per-protocol participation in that trial.

The aim of current study is to assess a sustained unresponsiveness (SU) to allergen protein after at least 8 months of previously assigned high- or low-dose peanut OIT, followed by 4-week-allergen avoidance, and verified by an open oral food challenge (OOFC).

Detailed Description

Oral immunotherapy is considered the most effective food allergy treatment. There are two main goals of food immunotherapy: achievement of desensitisation and sustained unresponsiveness. Desensitization is a temporary state of clinical non-reactivity which requires regular intake of allergen, whereas sustained unresponsiveness is defined as lack of clinical reaction to a food allergen after discontinuing OIT for a specific period of time.

The study is a continuation of a clinical trial NCT044155930, which was designed to compare the efficacy and safety of oral immunotherapy (OIT) with low or high doses of peanut protein (150 or 300 mg, respectively) in children with a confirmed diagnosis of peanut allergy. The participants of current study will be recruited from patients who have accomplished their per-protocol participation in previous trial.

Patients will receive the same maintenance dose of peanut allergen, which was used in previous trial (150 or 300 mg, respectively), for at least 8 months (32 weeks +/-2 weeks). Then, OIT will be discontinued for 4 weeks with strict peanut avoidance. After this period, an open oral food challenge (OOFC) will be performed to assess the achievement of sustained unresponsiveness.

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-20
• Study Start: 2022-02-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-29
• Last Update Posted: 2023-08-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	Low dose OIT	20 patients
High dose	High dose OIT	20 patients

Primary Outcome Measures

Name	Time	Method
Sustained unresponsiveness to a peanut protein after discontinuing oral immunotherapy for 4 weeks.	Up to 9 months after starting maintenance phase	The share of participants who tolerate a single dose of 150 mg or 300 mg of peanut protein (depending on the maintenance dose) at oral food challenge.
The highest tolerated dose of peanut protein after discontinuing oral immunotherapy for 4 weeks.	Up to 9 months after starting maintenance phase	Sustained unresponsiveness assessed as the highest tolerated dose of peanut protein at oral food challenge.

Secondary Outcome Measures

Name	Time	Method
Adverse events	Up to 9 months after starting maintenance phase	Number and severity of adverse events during OIT treatment and at OOFC will be assessed and compared between both groups.
Occurence of eosinophilic esophagitis.	Up to 9 months after starting maintenance phase	Number and severity of eosinophilic esophagitis symptoms following OIT treatment assessed and compared between both groups.
Laboratory data	Up to 9 months after starting maintenance phase	Change in serum levels of specific immunoglobulin E (sIgE) to peanut components and peanut-specific immunoglobulin G4 (sIgE4) levels at different time points: at the start and at the end of oral immunotherapy, and after 4 weeks of allergen avoidance, assessed for each individual and compared between groups.
Skin prick test (SPT)	Up to 9 months after starting maintenance phase	Change in peanut skin prick test wheal in different time points: at the start, and at the end of oral immunotherapy, and after 4 weeks of allergen avoidance, assessed for each individual and compared between groups.

Trial Locations

Locations (1)

Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw; 🇵🇱 Warsaw, Poland