UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030175 |
|---|---|
| Receipt number | R000034465 |
| Scientific Title | Efficacy of oral tolerance induction by Kakkonto in food allergy |
| Date of disclosure of the study information | 2017/12/15 |
| Last modified on | 2022/06/03 09:03:13 |
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Basic information
Public title
Efficacy of oral tolerance induction by Kakkonto in food allergy
Acronym
Efficacy of Kakkonto for food allergy
Scientific Title
Efficacy of oral tolerance induction by Kakkonto in food allergy
Scientific Title:Acronym
Efficacy of Kakkonto for food allergy
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Oral immunotherapy has been conducted for food allergy, but there are also many unresolved problems in safety due to strong allergic reactions.
Kakkonto, a traditional Japanese medicine, is reported to have an effect of suppressing the onset of food allergy in a mouse food allergy pathology model and may be an adjunctive treatment for oral immunotherapy for food allergy.
In this study, we evaluate the efficacy and safety by Kakkonto in combination with food allergy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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
Key secondary outcomes
4. Specific IgE/IgG4 antibody, cytokines, lymphocytes subsets
5. Prick test
6. Compliance of kakkonto
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
Take an intake instruction in a safe amount for a patient who is positive for oral food challenge test. We reevaluated the change in threshold by oral food challenge test.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 2 | years-old | <= |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key 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
Key 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
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Adachi |
Organization
Toyama University Hospital
Division name
Pediatrics
Zip code
930-0194
Address
2630 Sugitani, Toyama, Japan
TEL
81.76.434.2281
toyamakoit-group@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Ito |
Organization
Toyama University Hospital
Division name
Pediatrics
Zip code
930-0194
Address
2630 Sugitani, Toyama, Japan
TEL
81.76.434.2281
Homepage URL
yaitto-tym@umin.net
Sponsor or person
Institute
Toyama University
Institute
Department
Personal name
Funding Source
Organization
Toyama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
toyama univ
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama university
Address
2630 sugitani, toyama, japan
Tel
0764342281
yaitto-tym@umin.net
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
富山大学付属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 29 | Day |
Last modified on
| 2022 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034465
