UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034465