Clinical Trials

High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety

Study Purpose

In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with peanut protein in high and low dose (300mg versus 150mg) in children with peanuts allergy.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	4 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04415593
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medical University of Warsaw
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Klementyna Łyżwa, MD
Principal Investigator Affiliation	Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Poland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Allergy

Additional Details

Peanut allergy is a significant clinical problem. Food immunotherapy provides the latest approach to managing food allergy. Oral immunotherapy is considered as the most effective and safe, according to current research. What is more, this type of therapy is easily available and can be continued at patient's home. Obtaining and maintenance of tolerance to the allergic food is the main goal of this procedure. The study will include children with peanut allergy, confirmed during open oral food challenge (OOFC) with peanut protein. First OOFC will be performed before immunotherapy, second one at the end of procedure. Participants will be randomly assigned to two groups. During the maintenance phase, the first group will receive low dose of peanut protein, which amounts 150mg, the second will get high dose, which is 300 mg of peanut protein. Oral immunotherapy with low and high dose of peanut protein in children randomly assigned to two groups (1:1). In the following phase, every two weeks the dose of ground roasted peanut will be increased and applied to a child during hospitalization (1-day procedure). Precondition to increase of dose is good tolerance of previous portion of peanut. The maximum time frame for this phase is 14 months. After achieving tolerance, immunotherapy will be continued for 2 months in maintenance phase, with dose 150mg or 300 mg peanut protein, depending on a study group. The dosage increasing phase will last maximally 14 months. If patients achieves the maintenance dose earlier, this period may be shorter. Maintenance dose is determined by random patients' assignment to one from study's group and amounts 150mg or 300 mg of peanut protein, respectively. The duration of the maintenance phase is 8 weeks (+/-2 weeks). After 2 months (8 weeks +/-2 weeks) of maintenance dose the final OOFC and evaluation of tolerance of peanut protein will be performed. Confirmation of the total desensitization of peanut is the tolerance of a single dose of 4500 mg peanut protein.

Arms & Interventions

Arms

Experimental: high dose of peanut

20 patients

Active Comparator: low dose of peanuts

20 patients

Interventions

Dietary Supplement: - High dose of peanuts

Patients will receive a high dose of ground peanuts (300 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product

Dietary Supplement: - Low dose of peanuts

Patients will receive a low dose of ground peanuts (150 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Warsaw, Poland

Status

Recruiting

Address

Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw

Warsaw, , 02-091

Site Contact

Klementyna Łyżwa, MD

[email protected]

607153221

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