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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033350
Receipt No. R000038020
Official scientific title of the study Analysis of human gut microbiome in severe food allergic patients
Date of disclosure of the study information 2018/07/10
Last modified on 2018/07/10

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Basic information
Official scientific title of the study Analysis of human gut microbiome in severe food allergic patients
Title of the study (Brief title) Analysis of human gut microbiome in severe food allergic patients
Region
Japan

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

Objectives
Narrative objectives1 To analyze human gut microbiome in severe food allergic patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intestinal microbiota
Key secondary outcomes Short chain fatty acids (Acetic acid, butyric acid, propionic acid, valeric acid) in serum

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
5 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria GroupA:
Patients who developed objective symptoms during an oral food challenge to 1/32 of heated whole egg, 3 ml of heated cow's milk, 2g of Udon (Japanese wheat noodles), 0.5g of peanut or 0.5g of nut.
Patients who desired to receive oral immunotherapy.
GroupB:
Patients who were 5 years of age or older.
Patients who regularly visit our hospital for food allergy.
Patients who did not desire to receive oral immunotherapy.
GroupC:
Patients who were 5 years of age or older.
Patients who regularly visit our hospital for the exception of food allergy.
Patients who did not desire to receive oral immunotherapy.
Key exclusion criteria Decision of ineligibility by a physician
Target sample size 40

Research contact person
Name of lead principal investigator Noriyuki Yanagida
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Pediatrics
Address 18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Email s-satou@sagamihara-hosp.gr.jp

Public contact
Name of contact person Ken-ichi Nagakura
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of pediatrics
Address 18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Homepage URL
Email k-nagakura@sagamihara-hosp.gr.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus
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
2018 Year 07 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 05 Day
Anticipated trial start date
2018 Year 07 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Intestinal microbiota
Short chain fatty acids (Acetic acid, butyric acid, propionic acid, valeric acid) in serum

Management information
Registered date
2018 Year 07 Month 10 Day
Last modified on
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038020

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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