UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023453
Receipt No. R000027004
Scientific Title Clinical Studies of mechanism on oral tolerance induction by slow oral immunothrapy
Date of disclosure of the study information 2016/08/13
Last modified on 2019/08/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical Studies of mechanism on oral tolerance induction by slow oral immunothrapy
Acronym Clinical Studies on oral tolerance induction by slow oral immunothrapy
Scientific Title Clinical Studies of mechanism on oral tolerance induction by slow oral immunothrapy
Scientific Title:Acronym Clinical Studies on oral tolerance induction by slow oral immunothrapy
Region
Japan

Condition
Condition Food allergy
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal mechanism of oral tolerance induction
Basic objectives2 Others
Basic objectives -Others validation of the difference of immunoglobulin dynamics between Successful and non-successful
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Validation of Salava specific IgA for three years
Key secondary outcomes Validation of Serum specific IgE for three years

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 allergen foods are slowly increasing to the target amount and continuing its amount until tolerance induction.
Interventions/Control_2
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
5 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria food allergy patients who wish to join this study at the age of five or more.
Key exclusion criteria 1; Patients using beta-blockers, 2; patients who are pregnant at the time of the start of treatment, 3; Patient who has the unstable severe asthma, 4; Patients with systemically serious disease (malignant tumors, autoimmune diseases, immune deficiencies, severe heart disease, chronic infections, etc.), 5; patients using continuous use systemic corticosteroids or anti-cancer agents, and 6; Patients who are suffering from acute infection.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yasuto
Middle name
Last name Kondo
Organization Fujita Health University, Second teaching Hospital
Division name Department of Pediatrics, School of Medicine
Zip code 454-8509
Address 3-6-10, Otoubashi, Nakagawa, Nagoya
TEL 052-323-5649
Email ykondo@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Yasuto
Middle name
Last name Kondo
Organization Fujita Health University, Second teaching Hospital
Division name Department of Pediatrics
Zip code 454-8509
Address 3-6-10, Otoubashi, Nakagawa, Nagoya
TEL 052-323-5649
Homepage URL
Email ykondo@fujita-hu.ac.jp

Sponsor
Institute Department of Pediatrics, School of Medicine, Fujita Health University
Institute
Department

Funding Source
Organization Department of Pediatrics, School of Medicine, Fujita Health University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kyoto College of Nutritional & Medical Sciences
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fujita Health Uninersity
Address 1-98 Dengakugakubo Kutsukake, Toyoake, Aichi, Japan
Tel 0562-93-2865
Email irb-sys@fujita-hu.ac.jp

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 08 Month 13 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 Open public recruiting
Date of protocol fixation
2016 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 02 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027004

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.