Verification of the effectiveness of allergen-containing processed foods

JRCT ID: jRCTs041210080

Registered date:06/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Food Allergy
• Date of first enrollment: 06/10/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Daily intake group of test meal (causing food alone)
Daily intake group of test meal (cause food and lactic acid bacterium L-137 combined)
Implementation of allocation to standard instruction groups

Outcome(s)

• Primary Outcome: Ingestible amount of causative food in food oral challenge test 24 weeks after the start of the test

Secondary Outcome

Differences in the presence / absence and frequency of induced symptoms during the study period
Differences between groups of adherence
Differences between groups in the burden of parents
Differences between groups of specific IgE antibody titers (egg white, ovomucoid, milk, casein, wheat, omega-5 gliadin)-Specific IgG4 antibody titer
Differences in the number of Treg cells between groups
Differences between gut microbiota ratios and fecal short-chain fatty acid analysis values

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: < 12age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Kondo Yasuto
• Source(s) of Monetary Support: House Food Group Inc.