Wheat AllergyNCT03352193
Specific Oral Tolerance Induction (SOTI) to Children With IgE-mediated Wheat Allergy
An observational study of Wheat Allergy, run by Athens General Children's Hospital "Pan. & Aglaia Kyriakou" at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Wheat Allergy
- What is being tested?
- Wheat spaghetti
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- 1 siteGreece
- Study dates
- 8 Jan 2018to 10 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Wheat allergic patients visiting the Allergy Department of a tertiary University Children's Hospital
Who may be able to join
- Age 2-16 years
- Personal history of IgE-mediated allergy to wheat with unequivocal allergic reaction one year before study entry, and
- Positive SPT in wheat (> 3 mm), and/or
- Wheat specific IgE f4 > 0.35 kUa/L, and
- A positive Oral Food Challenge (OFC) to wheat, with the exception of patients who report a recent reaction (< 3 months before study entry) after the consumption of wheat products
- Signed written consent form of the parents.
Who cannot join
- Severe persistent or uncontrolled bronchial asthma or other lung disease (other than asthma), and/or
- Recent personal history (over the past 12 months) of severe anaphylactic reaction following wheat consumption, for which Intensive Care Unit (ICU) hospitalization was required, and/or
- Patients on specific immunotherapy, subcutaneous (SCIT) or sublingual (SLIT) or any other form of current immunotherapy or treatment with other biological agents, and/or
- Personal history of anaphylaxis due to wheat-dependent exercise induced anaphylaxis, and/or
- Patients with celiac disease or diagnosis other than IgE-mediated wheat allergy (eg eosinophilic gastrointestinal diseases), and/or
- Patients with cardiovascular disease or other significant systemic disease, and/or
- Patients presenting severe anaphylactic reaction to very low doses of wheat (eg. after administration of the 1st or 2nd dose during the baseline OFC).
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Department of Allergy and Clinical Immunology, 2nd Pediatric Clinic, General Children's Hospital P-A Kyriakou
Athens, 11527
Nikolaos Kitsioulis, MD, 00302132009160
About this study
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.
Read more
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).
Read the 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.
- Conditions
- Wheat Allergy
- Being tested
- Wheat spaghetti
- Medical subject headings
- Wheat Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat spaghettiDietary supplement
Wheat oral immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| SOTI group | Wheat spaghetti Receives: Dietary Supplement: Wheat spaghetti | |
| Historical control group | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheat allergic children achieving desensitization after 1 year of wheat home SOTI.
The rate of wheat allergic children achieving desensitization after 1 year of wheat home SOTI.
Measured: 1 year
Secondary outcomes (3)
Variability of Skin Prick Tests (SPTs) pre and post 1-year SOTI intervention
Determination of Skin Prick Tests (SPTs) of wheat allergic children pre and post 1-year SOTI intervention
Measured: 1 year
Total IgE, wheat specific IgE levels (f4, f79, f98, f416, f433) pre and post 1-year SOTI intervention
Determination of wheat allergic patients' total IgE, wheat specific IgE levels (f4, f79, f98, f416, f433) pre and post 1-year SOTI intervention
Measured: 1 year
Wheat basophil activation test (BAT) pre and post 1-year SOTI intervention
Determination of wheat allergic patients' basophils activation pre and post 1-year SOTI intervention via Basophil Activation Test (BAT)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start8 Jan 2018
- Primary completionOct 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wheat AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Kitsioulis, Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
- Investigators
- Nikolaos Kitsioulis, MD, Principal investigator, National and Kapodistrian University of AthensNikolaos Papadopoulos, MD, PhD, Study chair, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352193
- Sponsor's protocol ID
- Wheat SOTI
- Status last verified
- Jul 2024
- First submitted
- 20 Nov 2017
- Last updated
- 30 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Oral Tolerance Induction (SOTI) to Children With IgE-mediated Wheat Allergy
- ClinicalTrials.gov ID
- NCT03352193
- Acronym / sponsor ID
- Wheat SOTI
- Conditions
- Wheat Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Athens General Children's Hospital "Pan. & Aglaia Kyriakou"University, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOTI group | – | Dietary Supplement: Wheat spaghettiWheat spaghetti |
| Historical control group | – | –No intervention |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Wheat allergic patients visiting the Allergy Department of a tertiary University Children's Hospital
Key inclusion criteria (6 listed)
- Age 2-16 years
- Personal history of IgE-mediated allergy to wheat with unequivocal allergic reaction one year before study entry, and
- Signed written consent form of the parents.
Key exclusion criteria (7 listed)
- Severe persistent or uncontrolled bronchial asthma or other lung disease (other than asthma), and/or
- Recent personal history (over the past 12 months) of severe anaphylactic reaction following wheat consumption, for which Intensive Care Unit (ICU) hospitalization was required, and/or
- Patients on specific immunotherapy, subcutaneous (SCIT) or sublingual (SLIT) or any other form of current immunotherapy or treatment with other biological agents, and/or
- Personal history of anaphylaxis due to wheat-dependent exercise induced anaphylaxis, and/or
- Patients with celiac disease or diagnosis other than IgE-mediated wheat allergy (eg eosinophilic gastrointestinal diseases), and/or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheat spaghettiWheat oral immunotherapy | Dietary supplement | SOTI group |
Primary outcome
Wheat allergic children achieving desensitization after 1 year of wheat home SOTI.
Time frame: 1 year
The rate of wheat allergic children achieving desensitization after 1 year of wheat home SOTI.
3 secondary outcomes
Variability of Skin Prick Tests (SPTs) pre and post 1-year SOTI intervention
Time frame: 1 year
Total IgE, wheat specific IgE levels (f4, f79, f98, f416, f433) pre and post 1-year SOTI intervention
Time frame: 1 year
Wheat basophil activation test (BAT) pre and post 1-year SOTI intervention
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
Related trials for Wheat Allergy
Not yet recruitingPhase 2
A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy
Food Allergy, Wheat Hypersensitivity
RecruitingObservational study
Liver Steatosis and Fibrosis in Non-Celiac Wheat Sensitivity Patients: a Prospective Study
Metabolic Dysfunction-Associated Steatotic Liver Disease, Non Celiac Wheat Sensitivity
Active, not recruitingPhase 1
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
Food Allergy
Recruiting
NCWS or IBS/FD in Relatives of CD Patients
Non Celiac Wheat Sensitivity, IBS (Irritable Bowel Syndrome)
Recruiting
Urinary Gluten Immunogenic Peptides Detection in Non-celiac Gluten/Wheat Sensitivity
Non-celiac Gluten/Wheat Sensitivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Kitsioulis, MD principal investigator
National and Kapodistrian University of Athens
Nikolaos Papadopoulos, MD, PhD study chair
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wheat Allergy, run by Athens General Children's Hospital "Pan. & Aglaia Kyriakou" at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikolaos Kitsioulis, MD (00302132009160, drnok21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheat allergic children achieving desensitization after 1 year of wheat home SOTI. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.