Actively Recruiting

Phase Not Applicable
Age: 5Years - 18Years
All Genders
NCT06035328

Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Led by Mahidol University · Updated on 2025-05-09

64

Participants Needed

1

Research Sites

194 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Who Can Participate

Age: 5Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 5-18 years old
  • Children aged 5-18 years with history of IgE mediated wheat allergy and positive OFC test
  • Reached target maintenance dose of wheat OIT and ongoing in maintenance phase of wheat OIT
Not Eligible

You will not qualify if you...

  • Patients on low dose OIT protocol
  • Patients with uncontrolled atopic dermatitis, uncontrolled asthma, or any chronic disease
  • Patients treated with other immunotherapy (e.g., SLIT, another OIT) or biologic therapy (e.g., Omalizumab)
  • Patients with developmental problems or mental disorders
  • Active eosinophilic gastrointestinal disease in the past 2 years
  • Use of beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium-channel blockers
  • Pregnancy or lactation
  • Patients unable to visit clinic as required by protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Siriraj Hospital

Bangkoknoi, Bangkok, Thailand, 10700

Actively Recruiting

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Research Team

P

Punchama Pacharn, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy | DecenTrialz