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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age between 3 and 17 years, - IgE-mediated sesame allergy confirmed with positive skin prick tests with sesame allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35-kilo units of Allergen per liter (kUA/l), - Allergic reaction to sesame protein during oral food challenge (OFC), - Signed Informed Consent by parent/legal guardian and patient aged >16 years old, - Patient's and caregivers' cooperation with the researcher.

Exclusion Criteria:

- No confirmed sesame allergy, - Negative OFC with sesame protein (maximum dose 4000mg), - Severe asthma, uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)<80% (under 5.

percentile), FEV1/forced vital capacity (FVC)<75% (under 5. percentile), hospitalization due to asthma exacerbation within last 12 months,

- Current oral/sublingual/subcutaneous immunotherapy with other allergens in the first year of immunotherapy, - Eosinophilic gastroenteritis, - A history of severe recurrent anaphylaxis episodes, - Chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes, - Medication: - oral, daily steroid therapy longer than 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, - any biological treatment, - therapy with β-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel inhibitors, - Pregnancy, - No consent to participate in the study, - Lack of patient or caregiver cooperation.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06261554
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medical University of Warsaw
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Poland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy

Additional Details

Allergic reactions to sesame can be severe and life-threatening, making it challenging to avoid hidden sources of the allergen. This pilot study is a randomized controlled trial evaluating the efficacy and safety of oral immunotherapy (OIT) with a low-dose sesame protein in pediatric patients with sesame allergy. The study aims to compare participants undergoing OIT with a maintenance dose of 300mg sesame protein against a control group in a 2:1 randomized allocation. The control group will be recommended a standard treatment, which is a restrictive elimination diet and the use of emergency treatment, including adrenaline, in case of accidental exposure to sesame. 39 participants aged 3-17 with confirmed IgE-mediated sesame allergy will be enrolled into the study. Interventions will be administered once daily for up to 18 months, and the control group will stay under observation for one year. Primary outcomes include the proportion of participants tolerating a single dose of 4000mg sesame protein during the final oral food challenge. Secondary outcomes assess adverse events, changes in immunological parameters, and the maximum tolerated doses of sesame protein in each group.

Arms & Interventions

Arms

Experimental: Sesame immunotherapy

Children with sesame allergy receiving OIT.

No Intervention: Sesame avoidance

Children with sesame allergy not undergoing OIT.

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Medical University of Warsaw, Warsaw, Mazowieckie, Poland

Status

Recruiting

Address

Medical University of Warsaw

Warsaw, Mazowieckie, 02-091

Site Contact

Katarzyna Grzela, PhD, MD

[email protected]

+48 22 3179431

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