Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
Location status: Recruiting
Location contact
Punchama Pacharn, MD
CONTACT
NCT Number: NCT06035328
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
Interested in participating?
Request Info5 year–18 year
All sexes
Interventional
Not applicable
Bangkoknoi, Bangkok, 10700, Thailand
Location status: Recruiting
Punchama Pacharn, MD
CONTACT
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
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
Time frame: 13 months
Specific IgE to wheat
Time frame: 13 months
Specific IgG4 to wheat
Time frame: 13 months
Changing in Body weight in kilograms
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.
Time frame: 13 months
Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system
Time frame: 13 months
Quality of life before and after enrollment by using FAQLQ-PF
Contact information is provided by the study sponsor or research team.
Mahidol University
Other
Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy
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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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