Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2025-12-17 @ 4:24 AM
Study NCT ID:
NCT06261554
Status:
None
Last Update Posted:
2024-05-20 00:00:00
First Post:
2024-02-07 00:00:00
Brief Title:
Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official Title:
Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients: A Randomized Controlled Trial
Status:
None
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 21 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
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 21 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None