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Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients

NCT06261554 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-05-20

No results posted yet for this study

Summary

It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy.

Conditions

Interventions

DIETARY_SUPPLEMENT

Dietary Supplement: Low dose OIT

Following the building-up phase (up to 14 months), patients will receive a daily low dose of sesame paste (300 mg sesame protein) mixed with well-tolerated fruit mousse or bread for 3 months (12 +/- 3 weeks).

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2026-03-01
Completion
2027-03-01

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 NCT06261554 on ClinicalTrials.gov