ClinConnect ClinConnect Logo
Search / Trial NCT06035328

Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Launched by MAHIDOL UNIVERSITY · Sep 12, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Wheat Hypersensitivity Immunotherapy Short Term Unresponsiveness

ClinConnect Summary

This clinical trial is studying how effective two different schedules of wheat oral immunotherapy (OIT) are for people with a wheat allergy. Specifically, it compares taking a daily dose of the treatment versus taking it four times a week over a year. The goal is to see which method helps patients become less sensitive to wheat more effectively.

To participate, you need to be between 5 and 18 years old and have a confirmed wheat allergy. This means you have had a reaction to wheat and tested positive for this allergy in a supervised setting. If you join the study, you will take the treatment as directed and have regular check-ins at the clinic to monitor your progress. It’s important to note that some individuals, such as those with certain health conditions or who are pregnant, may not be eligible for this trial. If you have questions or think you might qualify, please reach out to the research team for more details.

Gender

ALL

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

About Mahidol University

Mahidol University, a premier institution in Thailand, is dedicated to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the university leverages its extensive expertise in medical and health sciences to facilitate rigorous scientific investigations aimed at improving patient care and public health outcomes. With a commitment to ethical practices and collaboration, Mahidol University fosters multidisciplinary approaches, engaging a diverse array of researchers and healthcare professionals to drive meaningful advancements in clinical research.

Locations

Bangkoknoi, Bangkok, Thailand

Patients applied

0 patients applied

Trial Officials

Punchama Pacharn, MD

Principal Investigator

Mahidol University, Siriraj Hospital,Thailand

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported