Health TrialsbyHealthPanel

Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

ConditionsWheat HypersensitivityImmunotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorMahidol University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Wheat (Four times per week)

    Other intervention

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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Four per weekExperimental treatment 1 intervention
Group B: Once dailyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Short term unresponsiveness rate

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

Secondary outcomes

1

Specific IgE to wheat

Specific IgE to wheat

Time frame
13 months
2

Specific IgG4 to wheat

Specific IgG4 to wheat

Time frame
13 months
3

Changing in Body weight

Changing in Body weight in kilograms

Time frame
13 months
4

Compliance

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
12 months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Siriraj HospitalRecruiting10700, Bangkoknoi, BangkokThailandThailand

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

Source ClinicalTrials.gov
Apply now