UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Kakkonto in oral immunotherapy for food Allergy : Randomized Controlled Trial
Title of the study (Brief title)	Efficacy of oral immunotherapy combinated Kakkonto
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	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Efficacy of oral immunotherapy induced acute reactions and side reaction by Kakkonto
Key secondary outcomes	1.Change of dose threshold in oral food challenge after 24 weeks of treatment 2.Specific IgE/IgG4 antibody, cytokines, lymphocytes subsets 3.Prick test 4.Compliance of kakkonto 5.Induced reactions during the maintenance

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	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Combination of anti-allergic drug and Kakkonto at introduction of oral immunotherapy for 5weeks
Interventions/Control_2	Combination of anti-allergic drug at introduction of oral immunotherapy for 5weeks
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	4 years-old <=
Age-upper limit	15 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	Yuichi Adachi
Organization	Toyama University Hospital
Division name	Pediatrics
Address	2630 Sugitani, Toyama, Japan
TEL	81.76.434.2281
Email	toyamakoit-group@umin.ac.jp

Public contact
Name of contact person	Yasunori Ito
Organization	Toyama University Hospital
Division name	Pediatrics
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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 29 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 12 Month 07 Day
Anticipated trial start date	2016 Year 12 Month 26 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 09 Month 18 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 29 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029315