UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019699
Receipt No. R000022757
Scientific Title Efficacy and safety of slow and rush oral immunotherapy for patients with food allergy
Date of disclosure of the study information 2015/11/16
Last modified on 2015/11/09

* 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 Efficacy and safety of slow and rush oral immunotherapy for patients with food allergy
Acronym Slow and rush oral immunotherapy for patients with food allergies
Scientific Title Efficacy and safety of slow and rush oral immunotherapy for patients with food allergy
Scientific Title:Acronym Slow and rush oral immunotherapy for patients with food allergies
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of slow oral immunotherapy combinaed with rush oral immunotherapy for patients with
food allergy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1. Evaluation of the symptom provocation threshold change at the time of entry and 12 months after the start of oral immunotherapy and frequencies of allergic symptoms during the 12 months.
Key secondary outcomes 1. Analysis of immunologic parameters in blood samples and measurements of prick test at entry, food challenge and 1 year late the entry.
2. Analysis of adverse effects during this clinical study.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Cow's milk, hen's egg, wheat, foods caused by allergy.
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
20 years-old >=
Gender Male and Female
Key inclusion criteria 1) The patients that have positive reactions at food challenge
2) The patients that show more than 0.35 UA/ml of specific IgE level and were positive for skin prick test
3) The patients that written informed consent is obtained
Key exclusion criteria 1) severe bronchial asthma
2) severe atopic dermatitis
3) acute severe illenes
4) Decision of ineligibility by a physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaya Takahashi
Organization Kansai Medical University
Division name Department of Pediatrics
Zip code
Address 2-3-1, shinmachi, Hirakata city, Osaka, Japan
TEL 072-804-0101
Email takahasm@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Takahashi
Organization Kansai Medical University
Division name Department of Pediatrics
Zip code
Address 2-3-1, shinmachi, Hirakata city, Osaka, Japan
TEL 072-804-0101
Homepage URL
Email takahasm@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization The Mami Mizutani foundation
Kansai Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 関西医科大学附属枚方病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 16 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
2015 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 16 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 04 Month 30 Day
Date trial data considered complete
2019 Year 05 Month 31 Day
Date analysis concluded
2019 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 09 Day
Last modified on
2015 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022757

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.