Efficacy of oral tolerance induction by Kakkonto in food allergy- Non-Randomized clinical trial
Phase 2
- Conditions
- Food allergyD005512
- Registration Number
- JPRN-jRCTs041180068
- Lead Sponsor
- omura Keiko
- Brief Summary
This study did not find a significant difference between the kakkonto oral administration group and non-oral administration group. Although the efficacy of oral kakkonto was not found in this study, no patient experienced severe adverse events associated with this medicine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 22
Inclusion 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
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Induced reaction during 24 weeks of treatment <br>2. Change of dose threshold in oral food challenge after 24 weeks of treatment <br>3. adverse reaction of kakkonto
- Secondary Outcome Measures
Name Time Method 1. Specific IgE/IgG4 antibody,cytokines,lymphocytes subsets <br>2. Compliance of kakkonto