High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety
In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with sesame protein in high and low dose (300mg versus 1200mg) in children with sesame allergy.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
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|Eligible Ages||4 Years - 17 Years|
- - medical history of sesame allergy, - IgE-mediated sesame allergy confirmed as 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) (UniCAP method), - reaction to sesame protein during OOFC (maximum dose 4000g), - signed Informed Consent by parent/legal guardian and patient aged >16 years old, - patient's/caregivers' cooperation with researcher.
- - no confirmed sesame allergy, - negative oral food challenge with sesame protein (maximum dose 4000g), - severe asthma, - uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)<80% (under 5.
- - current oral/sublingual/subcutaneous immunotherapy with other allergen, - 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 last 12 months, - at least two courses of oral steroid therapy (at least 7 days) within last 12 months, - oral steroid therapy longer than 7 days within last 3 months, - biological treatment, - the need to constantly take antihistamines, - therapy with β-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors, - pregnancy, - no consent to participate in the study, - lack of patient cooperation.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Medical University of Warsaw|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Katarzyna Grzela, MD, PhD|
|Principal Investigator Affiliation||Medical University of Warsaw|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Sesame allergy is an important global clinical problem affecting 0,2-0,8% population. In food allergy, allergen avoidance and emergency treatment are still therapeutic hallmarks. Oral and sublingual allergen-specific immunotherapies have been provided as a new approach to managing food allergy. The main goal of oral immunotherapy is to obtain the desensitization to food. The oral immunotherapy (OIT) is considered as safe and highly effective, according to current research. In addition, this type of therapy reduce the influence of food allergy in patient's live. Children 4 to 17 years old with sesame allergy will be enrolled into study. Skin prick test with condiment made from toasted ground hulled sesame and open oral food challenge (OOFC) will be performed at the baseline and at the end of procedure. Blood will be analyzed for specific IgE, IgG4 levels and basophil activation test before and after OIT. OIT will consisted of two parts: dosage increase phase and maintenance phase. The Participants will be randomized (1:1) to receive sesame OIT with maintenance dose of 300 mg or 1200 mg sesame protein. In the dosage increase phase, the dose of condiment made from toasted ground hulled sesame will be gradually increased every two weeks and administrated to a child during hospitalization (1-day procedure). Precondition to increase of dose is good tolerance of previous portion of condiment made from toasted ground hulled sesame. The maximum time frame for this phase is 14 months. After achieving tolerance, immunotherapy will be continued for 3 months in maintenance phase, with dose 300mg or 1200 mg sesame protein. Maintenance dose is determined by random patients' assignment to one from study's . After 3 months (12 weeks +/-2 weeks) of maintenance dose the final OOFC and evaluation of desensitization of sesame protein will be performed. Confirmation of the total desensitization to sesame is the tolerance of a single dose of 4000 mg sesame protein.
Experimental: High dose
Experimental: high dose of sesame 20 patients
Active Comparator: Low dose
Active Comparator: low dose of sesame 20 patients
Dietary Supplement: - High dose
Patients will receive a high dose of sesame paste or flour (1200 mg of sesame protein) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product
Dietary Supplement: - Low dose
Patients will receive a low dose of sesame paste or flour (300 mg of sesame protein) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product
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Warsaw, , 02-091
Katarzyna Grzela, PhD, MD