Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-05 @ 9:53 PM
Study NCT ID:
NCT03352193
Status:
RECRUITING
Last Update Posted:
2024-07-30
First Post:
2017-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specific Oral Tolerance Induction (SOTI) to Children With IgE-mediated Wheat Allergy
Sponsor:
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
Organization:
Study Overview
Official Title:
Specific Oral Tolerance Induction (SOTI) to Children With IgE-mediated Wheat Allergy
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This is an observational pilot study investigating the effectiveness, safety and specific immunological mechanisms of Specific Oral Tolerance Induction (SOTI) in children with IgE-mediated wheat allergy.
The study will include 10 patients with persistent IgE-mediated allergy to wheat, who will undergo 1-year home SOTI. Moreover, 5 patients with IgE-mediated allergy to wheat will be followed for 1-year period after their diagnosis, without any intervention.
Well-cooked wheat spaghetti will be given daily to patients with a programmed weekly dose increment for 27 weeks (up-dosing phase).
Subsequently, wheat protein maintenance dose will be received daily for additional 6 months (maintenance phase), while afterwards patients will be clinically assessed and a 2nd OFC at a higher cumulative dose of wheat protein will be performed, in order to assess patients' desensitization to wheat.
Skin Prick Tests (SPTs) to wheat, blood sampling for the determination of total IgE, wheat specific IgEs and wheat Basophil Activation Test (BAT) will be performed at baseline, when patients reach the maintenance dose and before the 2nd OFC.
Regarding historical control group the same testing will be performed at baseline and at re-evaluation (post 12 months).
The study will include 10 patients with persistent IgE-mediated allergy to wheat, who will undergo 1-year home SOTI. Moreover, 5 patients with IgE-mediated allergy to wheat will be followed for 1-year period after their diagnosis, without any intervention.
Well-cooked wheat spaghetti will be given daily to patients with a programmed weekly dose increment for 27 weeks (up-dosing phase).
Subsequently, wheat protein maintenance dose will be received daily for additional 6 months (maintenance phase), while afterwards patients will be clinically assessed and a 2nd OFC at a higher cumulative dose of wheat protein will be performed, in order to assess patients' desensitization to wheat.
Skin Prick Tests (SPTs) to wheat, blood sampling for the determination of total IgE, wheat specific IgEs and wheat Basophil Activation Test (BAT) will be performed at baseline, when patients reach the maintenance dose and before the 2nd OFC.
Regarding historical control group the same testing will be performed at baseline and at re-evaluation (post 12 months).
Detailed Description:
This is an observational pilot study investigating the effectiveness, safety and specific immunological mechanisms of Specific Oral Tolerance Induction (SOTI) in children aged 2-16 years with IgE-mediated wheat allergy. The study will be conducted in the Department of Allergy and Clinical Immunology, 2nd University Pediatric Clinic of "Panagiotis \& Aglaia Kyriakou" Children's Hospital, Athens, Greece.
The study will include 10 patients with persistent IgE-mediated allergy to wheat, who will undergo 1-year home SOTI, defined as SOTI group. Moreover, 5 patients with IgE-mediated allergy to wheat will be followed for 1-year period after their diagnosis, without any intervention, either because of denial or due to positive history of severe anaphylaxis to very low doses of wheat during baseline Oral Food Challenge / OFC or home ingestion in the preceding 3 months. These will be defined as historical control group.
Well-cooked wheat spaghetti will be given daily to patients with a programmed weekly dose increment for 27 weeks (up-dosing phase). Three different home starting doses will be pre-determined in accordance to each individual's reactivity threshold during baseline OFC to wheat. Each proposed starting dose will be associated with a different weekly stable increase ratio of wheat intake, so that all patients reach an equal predefined maintenance dose at week 27 of up-dosing phase.
Subsequently, wheat protein maintenance dose (spaghetti or equivalent quantity of wheat protein of other wheat product) will be received daily for additional 6 months (maintenance phase), while afterwards patients will be clinically assessed and a 2nd OFC at a higher cumulative dose of wheat protein will be performed, in order to assess patients' desensitization to wheat.
Skin Prick Tests (SPTs) to wheat, blood sampling for the determination of total IgE, wheat specific IgEs (f4, f79, f98, f416, f433) and wheat Basophil Activation Test (BAT) will be performed at baseline, when patients reach the maintenance dose and before the 2nd OFC. Additionally, blood sampling for determination of the levels of anti-tissue transglutaminase (tTG)-IgA/IgG and anti-endomysial (EMA)-IgA antibodies at baseline and post study completion will be performed.
Regarding historical control group the same testing (except anti-tTG and anti-EMA) will be performed at baseline visit and at re-evaluation (post 12 months). All children and / or their parents / legal guardians will be trained in the use of self-injectable epinephrine in case of severe allergic reactions and a detailed treatment plan will be given by the study doctors. Written information sheet will be provided and written consent will be obtained from all parents/legal guardians.
The study will include 10 patients with persistent IgE-mediated allergy to wheat, who will undergo 1-year home SOTI, defined as SOTI group. Moreover, 5 patients with IgE-mediated allergy to wheat will be followed for 1-year period after their diagnosis, without any intervention, either because of denial or due to positive history of severe anaphylaxis to very low doses of wheat during baseline Oral Food Challenge / OFC or home ingestion in the preceding 3 months. These will be defined as historical control group.
Well-cooked wheat spaghetti will be given daily to patients with a programmed weekly dose increment for 27 weeks (up-dosing phase). Three different home starting doses will be pre-determined in accordance to each individual's reactivity threshold during baseline OFC to wheat. Each proposed starting dose will be associated with a different weekly stable increase ratio of wheat intake, so that all patients reach an equal predefined maintenance dose at week 27 of up-dosing phase.
Subsequently, wheat protein maintenance dose (spaghetti or equivalent quantity of wheat protein of other wheat product) will be received daily for additional 6 months (maintenance phase), while afterwards patients will be clinically assessed and a 2nd OFC at a higher cumulative dose of wheat protein will be performed, in order to assess patients' desensitization to wheat.
Skin Prick Tests (SPTs) to wheat, blood sampling for the determination of total IgE, wheat specific IgEs (f4, f79, f98, f416, f433) and wheat Basophil Activation Test (BAT) will be performed at baseline, when patients reach the maintenance dose and before the 2nd OFC. Additionally, blood sampling for determination of the levels of anti-tissue transglutaminase (tTG)-IgA/IgG and anti-endomysial (EMA)-IgA antibodies at baseline and post study completion will be performed.
Regarding historical control group the same testing (except anti-tTG and anti-EMA) will be performed at baseline visit and at re-evaluation (post 12 months). All children and / or their parents / legal guardians will be trained in the use of self-injectable epinephrine in case of severe allergic reactions and a detailed treatment plan will be given by the study doctors. Written information sheet will be provided and written consent will be obtained from all parents/legal guardians.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: