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Tests treatment safety and results for Food Allergy
Official title Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
ClinicalTrials.gov ID: NCT06261554
What this study is testing
- What it's testing
- 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.
- Time commitment: about 18 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 17
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Current oral/sublingual/subcutaneous immunotherapy with other allergens in the first year of immunotherapy,
- Eosinophilic gastroenteritis,
- A history of severe recurrent anaphylaxis episodes,
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Masovian Voivodeship, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Masovian Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.