High & Low Dose Oral Sesame Immunotherapy

Status Recruiting

Clinical Trial Summary

In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with sesame protein in high and low dose (300mg versus 1200mg) in children with sesame allergy.

Clinical Trial Description

Sesame allergy is an important global clinical problem affecting 0,2-0,8% population. In food allergy, allergen avoidance and emergency treatment are still therapeutic hallmarks. Oral and sublingual allergen-specific immunotherapies have been provided as a new approach to managing food allergy. The main goal of oral immunotherapy is to obtain the desensitization to food. The oral immunotherapy (OIT) is considered as safe and highly effective, according to current research. In addition, this type of therapy reduce the influence of food allergy in patient's live. Children 4 to 17 years old with sesame allergy will be enrolled into study. Skin prick test with condiment made from toasted ground hulled sesame and open oral food challenge (OOFC) will be performed at the baseline and at the end of procedure. Blood will be analyzed for specific IgE, IgG4 levels and basophil activation test before and after OIT. OIT will consisted of two parts: dosage increase phase and maintenance phase. The Participants will be randomized (1:1) to receive sesame OIT with maintenance dose of 300 mg or 1200 mg sesame protein. In the dosage increase phase, the dose of condiment made from toasted ground hulled sesame will be gradually increased every two weeks and administrated to a child during hospitalization (1-day procedure). Precondition to increase of dose is good tolerance of previous portion of condiment made from toasted ground hulled sesame. The maximum time frame for this phase is 14 months. After achieving tolerance, immunotherapy will be continued for 3 months in maintenance phase, with dose 300mg or 1200 mg sesame protein. Maintenance dose is determined by random patients' assignment to one from study's . After 3 months (12 weeks +/-2 weeks) of maintenance dose the final OOFC and evaluation of desensitization of sesame protein will be performed. Confirmation of the total desensitization to sesame is the tolerance of a single dose of 4000 mg sesame protein. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05158413
Study type	Interventional
Source	Medical University of Warsaw
Contact	Katarzyna Grzela, MD, PhD
Phone	+48 22 3179431
Email	katarzyna.grzela@wum.edu.pl
Status	Recruiting
Phase	N/A
Start date	March 31, 2022
Completion date	June 30, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety — Sesame

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms