UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of quality of life of patients with food allergy and their guardians using a questionnaire
Acronym	Evaluation of quality of life of patients with food allergy and their guardians
Scientific Title	Evaluation of quality of life of patients with food allergy and their guardians using a questionnaire
Scientific Title:Acronym	Evaluation of quality of life of patients with food allergy and their guardians
Region	Japan

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

Objectives
Narrative objectives1	Assessing the quality of life (QOL) of patients with food allergies and their guardians over time
Basic objectives2	Others
Basic objectives -Others	Assessing the clinical course and the patient parameters that impact QOL
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time course of changes in quality of life for patients and guardians
Key secondary outcomes	Relationship between clinical course of food allergy and QOL Influence of the course of oral food challenge or oral immunotherapy on QOL Correlation between immunological changes and the score of QOL Relationship between patient's clinical profile and QOL

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1 months-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients diagnosed by a physician with food allergy and their guardians
Key exclusion criteria	Decision of ineligibility by a physician
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Noriyuki Middle name Last name Yanagida
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Department of pediatrics
Zip code	252-0392
Address	18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL	042-742-8311
Email	yana@foodallergy.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name Miura
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Department of pediatrics
Zip code	252-0392
Address	18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL	042-742-8311
Homepage URL
Email	yoko6299@gmail.com

Sponsor
Institute	National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization	no funding
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Sagamihara Hospital Ethics Committee of the National Hospital Organization
Address	18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel	042-742-8311
Email	222-rinri@mail.hosp.go.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	2021 Year 07 Month 05 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	2021 Year 05 Month 25 Day
Date of IRB	2021 Year 06 Month 28 Day
Anticipated trial start date	2021 Year 07 Month 05 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Parents of patients with food allergies and patients aged 9 years and older receive a web-based or paper questionnaire at the time of consent and annually afterwards.

Management information
Registered date	2021 Year 07 Month 03 Day
Last modified on	2021 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051107