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

Launched by MEDICAL UNIVERSITY OF WARSAW · Dec 6, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment for peanut allergy using oral immunotherapy (OIT), which involves giving patients small doses of peanut protein to help their bodies become less sensitive to peanuts. The study is looking for participants who have already completed an earlier trial and will assess whether they can maintain a reduced allergic response to peanuts after avoiding peanuts for four weeks. This will be confirmed through a food challenge, where participants will be given peanuts in a controlled setting to see how they react.

To be eligible, participants need to have completed the previous trial, and if they are under 18, a parent or guardian must give consent. They should also be cooperative with the researchers. However, those with severe asthma, certain medical conditions, or who are currently receiving other allergy treatments may not qualify. If you decide to participate, you can expect to follow a specific protocol and be monitored closely for your safety. This trial is currently recruiting participants, so it’s a great opportunity for individuals looking to manage their peanut allergy more effectively.

Gender

ALL

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