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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030175
Receipt No. 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 2019/06/01

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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
Email 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
Email yaitto-tym@umin.net

Sponsor
Institute Toyama University
Institute
Department

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
Email 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 Enrolling by invitation
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
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2023 Year 03 Month 31 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 29 Day
Last modified on
2019 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034465

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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