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NCT Number: NCT06035328

Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

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

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location status: Recruiting

Location contact

Punchama Pacharn, MD

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wheat (Four times per week)

Other

Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT

Primary outcomes

  1. 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

Secondary outcomes

  1. Specific IgE to wheat

    Time frame: 13 months

    Specific IgE to wheat

  2. Specific IgG4 to wheat

    Time frame: 13 months

    Specific IgG4 to wheat

  3. Changing in Body weight

    Time frame: 13 months

    Changing in Body weight in kilograms

  4. Compliance

    Time frame: 12 months

    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.

  5. Adverse reactions

    Time frame: 13 months

    Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system

  6. Quality of life by using FAQLQ-PF

    Time frame: 13 months

    Quality of life before and after enrollment by using FAQLQ-PF

Study contacts

Contact information is provided by the study sponsor or research team.

Punchama Pacharn, MD

CONTACT

[email protected]

024197000 ext. 5670

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 13, 2023
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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