Efficacy of oral tolerance induction by Kakkonto in food allergy - Non-Randomized clinical trial-

JRCT ID: jRCTs041180068

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Food allergy
• Date of first enrollment: 13/12/2017
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Take an intake instruction in a safe amount for a patient who is positive for oral food challenge test. We used Kakkonto for 24 weeks together and reevaluated the change in threshold by oral food challenge test.

Outcome(s)

Primary Outcome

1. Induced reaction during 24 weeks of treatment
2. Change of dose threshold in oral food challenge after 24 weeks of treatment
3. adverse reaction of kakkonto

Secondary Outcome

1. Specific IgE/IgG4 antibody,cytokines,lymphocytes subsets
2. Compliance of kakkonto

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: < 20age old
• Gender: Both

Include criteria

1.Food allergy diagnosised by oral food challenge without tendency of natural outgrow
2. Children who obtain the informed consent of the study
3. Those who can take medicine of kakkonto
4. Patients who have secured medical institutions in emergency

Exclude criteria

1.Complication or past history of heart, liver and kidney diseases.
2.Uncontrolled asthma, atopic dermatitis, allergic rhinitis
3.Children who were judged as inappropriate by the study director

Related Information

• Primary Sponsor: Nomura Keiko
• Source(s) of Monetary Support: Natural medicine biotechnology research (Toyama),Nipponham Foundation for the Future of Food