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

NCT05163574 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-01

No results posted yet for this study

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).

Conditions

Interventions

DIETARY_SUPPLEMENT

High dose OIT

Patients will receive daily a high dose of peanut flour (300 mg peanut protein) mixed with well-tolerated fruit mousse.

DIETARY_SUPPLEMENT

Low dose OIT

Patients will receive daily a low dose of peanut flour (150 mg peanut protein) mixed with well-tolerated fruit mousse.

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Katarzyna Grzela, MD, PhD · Medical University of Warsaw

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-05
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05163574 on ClinicalTrials.gov