Actively Recruiting

Phase Not Applicable
Age: 3Years - 17Years
All Genders
ID06261554

Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients: A Randomized Controlled Trial

Led by Medical University of Warsaw · Updated on 2024-05-20

39

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The trial investigates low-dose oral immunotherapy (OIT) using sesame protein in children aged 3 to 17 years with confirmed IgE-mediated sesame allergy. It compares this treatment with standard care, which involves an elimination diet and emergency treatment. The goal is to assess whether OIT can increase tolerance to sesame and improve safety outcomes in this pediatric population. Participants are randomly assigned in a 2:1 ratio to either receive OIT with a daily maintenance dose of 300 mg sesame protein mixed with fruit mousse or bread, or to follow a control group that maintains a strict elimination diet without OIT. The OIT group undergoes a build-up phase lasting up to 14 months followed by 3 months of maintenance treatment. The control group is observed for one year without immunotherapy. During the study, children will be monitored for ability to tolerate sesame protein through oral food challenges, adverse events, and changes in immune responses measured by laboratory tests, skin prick tests, and basophil activation tests. The primary outcome measures tolerance to a 4000 mg dose of sesame protein up to 18 months after starting treatment. Safety and immune response data will also be collected during this period. Total participation lasts up to 18 months, with ongoing assessments throughout.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 3Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 3 and 17 years
  • Confirmed IgE-mediated sesame allergy with positive skin prick test (wheal >3mm) and/or specific IgE >0.35 kUA/l
  • Allergic reaction to sesame protein during oral food challenge
  • Signed informed consent by parent/legal guardian and patient if older than 16 years
  • Cooperation of patient and caregivers with researchers
Not Eligible

You will not qualify if you...

  • No confirmed sesame allergy
  • Negative oral food challenge with sesame protein (up to 4000 mg)
  • Severe or uncontrolled asthma, or hospitalization for asthma in last 12 months
  • Current oral, sublingual, or subcutaneous immunotherapy for other allergens within the first year
  • Eosinophilic gastroenteritis
  • History of severe recurrent anaphylaxis episodes
  • Chronic diseases requiring continuous treatment such as heart disease, epilepsy, metabolic diseases, diabetes
  • Recent or ongoing steroid or biological treatments
  • Use of beta-blockers, ACE inhibitors, or calcium channel blockers
  • Pregnancy
  • Lack of consent or cooperation from patient or caregiver

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 18 months

Participants receive daily low-dose sesame oral immunotherapy or follow a sesame avoidance diet, depending on their group assignment.

Regular visits for monitoring throughout treatment

Trial Site Locations

Total: 1 location

1

Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland, 02-091

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Research Team

K

Katarzyna Grzela, PhD, MD

J

Joanna Zielińska, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Prevalence of challenge-proven IgE-mediated food allergy using population-based sampling and predetermined challenge criteria in infants.

Nicholas J Osborne, Jennifer J Koplin, Pamela E Martin...

https://pubmed.ncbi.nlm.nih.gov/21377036