Skip to content

Verification of the effectiveness of allergen-containing processed foods

Verification of the effectiveness of allergen-containing processed foods in dietary guidance for children with food allergies

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041210080
Enrollment
60
Registered
2021-10-06
Start date
2021-10-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Allergy Food Allergy

Interventions

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

Sponsors

Kondo Yasuto
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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 6 months to 18 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Ingestible amount of causative food in food oral challenge test 24 weeks after the start of the test

Secondary

MeasureTime frame
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

Contacts

Public ContactNakajima Yoichi

Fujita Health University Department of pediatrics

ynakaji@fujita-hu.ac.jp+81-562-93-9251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026