An interventional study of High dose OIT and Low dose OIT in Peanut Allergy, sponsored by Medical University of Warsaw. Recruiting at 1 site in Poland. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment
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).
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.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
medication:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20 patients
Dietary Supplement: High dose OIT
20 patients
Dietary Supplement: Low dose OIT
Patients will receive daily a high dose of peanut flour (300 mg peanut protein) mixed with well-tolerated fruit mousse.
Patients will receive daily a low dose of peanut flour (150 mg peanut protein) mixed with well-tolerated fruit mousse.
Sustained unresponsiveness to a peanut protein after discontinuing oral immunotherapy for 4 weeks.
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.
Time frame: Up to 9 months after starting maintenance phase
The highest tolerated dose of peanut protein after discontinuing oral immunotherapy for 4 weeks.
Sustained unresponsiveness assessed as the highest tolerated dose of peanut protein at oral food challenge.
Time frame: Up to 9 months after starting maintenance phase
Adverse events
Number and severity of adverse events during OIT treatment and at OOFC will be assessed and compared between both groups.
Time frame: Up to 9 months after starting maintenance phase
Occurence of eosinophilic esophagitis.
Number and severity of eosinophilic esophagitis symptoms following OIT treatment assessed and compared between both groups.
Time frame: Up to 9 months after starting maintenance phase
Laboratory data
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.
Time frame: Up to 9 months after starting maintenance phase
Skin prick test (SPT)
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.
Time frame: Up to 9 months after starting maintenance phase
Plan to share: No
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