Verification of the effectiveness of allergen-containing processed foods
- Conditions
- Food AllergyD005512
- Registration Number
- JPRN-jRCTs041210080
- Lead Sponsor
- Kondo Yasuto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Patients who have received sufficient explanation before participating in this study, and who have obtained written consent at the discretion of the patient or his / her substitute with sufficient understanding.
2. Patients aged 1 to 12 at the time of consent
3. Patients diagnosed by a doctor as having a chicken egg, milk or wheat allergy
4. Patients with threshold values between 0.1 g and 18 g of heated egg white, 0.1 mL and 50 mL of milk, and 0.1 g and 50 g of udon noodles in an oral food challenge test conducted within the past 3 months
1. Patients with severe anaphylaxis due to ingestion of causative foods of 0.1 g, 0.1 mL or less within the past year
2. Patients with severe complications
3. In addition, patients who are judged to be inappropriate by the principal investigator and the research coordinator
4. Patients who consume causative foods above the confirmed threshold at home
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ingestible amount of causative food in food oral challenge test 24 weeks after the start of the test
- Secondary Outcome Measures
Name Time Method Differences in the presence / absence and frequency of induced symptoms during the study period<br>Differences between groups of adherence<br>Differences between groups in the burden of parents<br>Differences between groups of specific IgE antibody titers (egg white, ovomucoid, milk, casein, wheat, omega-5 gliadin)-Specific IgG4 antibody titer<br>Differences in the number of Treg cells between groups<br>Differences between gut microbiota ratios and fecal short-chain fatty acid analysis values