Wheat HypersensitivityNCT06035328
Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy
A study testing Wheat (Four times per week) in people with Wheat Hypersensitivity and Immunotherapy, run by Mahidol University at 1 site in Thailand.
Trial summary
Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not standardized, and a wide heterogeneity exists in the literature . So the purpose of our study is to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Wheat Hypersensitivity, Immunotherapy
- What is being tested?
- Wheat (Four times per week)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2023to 22 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 5-18 years old
- Children aged 5-18 years with history of IgE mediated wheat allergy and positive OFC test
- Reach target maintenance dose of wheat OIT and ongoing to maintenance phase of wheat OIT
Who cannot join
- Patient with low dose OIT protocol
- Patients with uncontrolled atopic dermatitis, uncontrolled asthma, or any chronic disease;
- Patients who had been treated with some other immunotherapy (eg, SLIT, another OIT) or biologic therapy (eg, Omalizumab)
- Patients with a developmental problem or mental disorder
- Active eosinophilic gastrointestinal disease in the past 2 years
- Use of b-blockers (oral), angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium-channel blockers
- Pregnancy or lactation
- Patient who could not visit clinic as protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkoknoi, Bangkok, 10700
Punchama Pacharn, MD
About this study
Official title: Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy
Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not standardized, and a wide heterogeneity exists in the literature . So the purpose of our study is to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT
Read the detailed description
All subject in this study were patients with history of IgE mediated wheat allergy and positive OFC test. All of them received wheat OIT and reached target maintenance dose of wheat OIT.
The primary outcome was to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT. Other outcomes were collected during the projected such as blood and skin examination for immunologic parameter, changing in Body weight, WA, WH and BMI, compliance, adverse reactions, rates of medication used during OIT and quality of life
- Conditions
- Wheat Hypersensitivity, Immunotherapy
- Being tested
- Wheat (Four times per week)
- Keywords
- Wheat Hypersensitivity, Immunotherapy, Short term unresponsiveness
- 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 (Four times per week)Other
Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
| Study group | Role | What they receive |
|---|---|---|
| Four per week | Experimental | Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT Receives: Other: Wheat (Four times per week) |
| Once daily | No intervention | Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term unresponsiveness rate
Short term unresponsiveness rate between once daily dose and four times/week dose .during maintenance phase of wheat OIT.
Short term unresponsiveness means patients who pass the oral food challenge test after stopping oral immunotherapy for a short period
Measured: 13 months
Secondary outcomes (6)
Specific IgE to wheat
Specific IgE to wheat
Measured: 13 months
Specific IgG4 to wheat
Specific IgG4 to wheat
Measured: 13 months
Changing in Body weight
Changing in Body weight in kilograms
Measured: 13 months
Compliance
Compliance of wheat ingestion (group A: every day, groupB: 4 days/weeks). Compliance can be calculated by dividing the number of days on which wheat is actually ingested by the total number of days prescribed for wheat consumption.
Measured: 12 months
Adverse reactions
Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system
Measured: 13 months
Quality of life by using FAQLQ-PF
Quality of life before and after enrollment by using FAQLQ-PF
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jul 2023
- Primary completion22 Mar 2027 (estimated)
- Study completion22 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wheat HypersensitivityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Punchama Pacharn, MD, Principal investigator, Mahidol University, Siriraj Hospital,Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035328
- Sponsor's protocol ID
- 069/2566(IRB3)
- Status last verified
- May 2025
- First submitted
- 18 Apr 2023
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
PubMed 29205393
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy
- ClinicalTrials.gov ID
- NCT06035328
- Acronym / sponsor ID
- 069/2566(IRB3)
- Conditions
- Wheat Hypersensitivity, Immunotherapy
- Keywords
- Wheat Hypersensitivity, Immunotherapy, Short term unresponsiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 22 Mar 2027 (estimated)
- Study completion
- 22 Mar 2027 (estimated)
- First posted
- 13 Sep 2023 (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.
Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not standardized, and a wide heterogeneity exists in the literature . So the purpose of our study is to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT
Detailed description
All subject in this study were patients with history of IgE mediated wheat allergy and positive OFC test. All of them received wheat OIT and reached target maintenance dose of wheat OIT.
The primary outcome was to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT. Other outcomes were collected during the projected such as blood and skin examination for immunologic parameter, changing in Body weight, WA, WH and BMI, compliance, adverse reactions, rates of medication used during OIT and quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Four per week | Experimental | Other: Wheat (Four times per week)Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT |
| Once daily | No intervention | –Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 5-18 years old
- Children aged 5-18 years with history of IgE mediated wheat allergy and positive OFC test
- Reach target maintenance dose of wheat OIT and ongoing to maintenance phase of wheat OIT
Key exclusion criteria (8 listed)
- Patient with low dose OIT protocol
- Patients with uncontrolled atopic dermatitis, uncontrolled asthma, or any chronic disease;
- Patients who had been treated with some other immunotherapy (eg, SLIT, another OIT) or biologic therapy (eg, Omalizumab)
- Patients with a developmental problem or mental disorder
- Active eosinophilic gastrointestinal disease in the past 2 years
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 (Four times per week)Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT | Other | Four per week |
Primary outcome
Short term unresponsiveness rate
Time frame: 13 months
Short term unresponsiveness rate between once daily dose and four times/week dose .during maintenance phase of wheat OIT. Short term unresponsiveness means patients who pass the oral food challenge test after stopping oral immunotherapy for a short period
6 secondary outcomes
Specific IgE to wheat
Time frame: 13 months
Specific IgG4 to wheat
Time frame: 13 months
Changing in Body weight
Time frame: 13 months
Compliance
Time frame: 12 months
Adverse reactions
Time frame: 13 months
Quality of life by using FAQLQ-PF
Time frame: 13 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Background: PubMed 29205393Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
- Individual participant dataSharing planned: No
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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.
Punchama Pacharn, MD principal investigator
Mahidol University, Siriraj Hospital,Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat (Four times per week) in people with Wheat Hypersensitivity and Immunotherapy, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 May 2025. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Punchama Pacharn, MD (024197000 ext. 5670, punchama@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term unresponsiveness rate (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035328, which also lists 1 linked publication.
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 9 May 2025.