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

Not Applicable

Recruiting

• Conditions: Food Allergy

• Registration Number: NCT06261554
• Lead Sponsor: Medical University of Warsaw

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-15
• Study Start: 2024-03-14
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-20
• Primary Completion: 2026-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tolerance of sesame	Up to 18 months after starting oral immunotherapy	The proportion of participants who tolerate the single dose of 4000mg sesame protein at the conclusion of the study.

Secondary Outcome Measures

Name	Time	Method
Adverse event	Up to 18 months after starting oral immunotherapy	Quantity and severity of adverse effect, assessed and compared between groups, divided into 3 categories: mild, moderate and severe reactions
Skin prick test (SPT)	Up to 18 months after starting oral immunotherapy	Change in skin prick test reactivity to sesame protein from baseline to end of treatment, compared between groups.
Basophil activation test	Up to 18 months after starting oral immunotherapy	The basophil activation test (BAT) results compared between groups at the end of treatment.
Laboratory data	Up to 18 months after starting oral immunotherapy	Difference in sesame serum immunoglobulin E (IgE) level and immunoglobulin G4 (IgG4) level, compared between groups at the end of treatment.
Desensitization dose	Up to 18 months after starting oral immunotherapy	Change in maximum tolerated dose of sesame in oral food challenge before and in the end of treatment, compared between groups.

Trial Locations

Locations (1)

Medical University of Warsaw; 🇵🇱 Warsaw, Mazowieckie, Poland