NCT06035328 Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy
| NCT ID | NCT06035328 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Wheat Hypersensitivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2027-03-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2023-07-01 with a primary completion date of 2027-03-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 wheat OIT
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Punchama Pacharn, MD
PRINCIPAL INVESTIGATOR
Mahidol University, Siriraj Hospital,Thailand
Frequently Asked Questions
Who can join the NCT06035328 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 18 Years, studying Wheat Hypersensitivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06035328 currently recruiting?
Yes, NCT06035328 is actively recruiting participants. Contact the research team at punchama@gmail.com for enrollment information.
Where is the NCT06035328 trial being conducted?
This trial is being conducted at Bangkoknoi, Thailand.
Who is sponsoring the NCT06035328 clinical trial?
NCT06035328 is sponsored by Mahidol University. The principal investigator is Punchama Pacharn, MD at Mahidol University, Siriraj Hospital,Thailand. The trial plans to enroll 64 participants.