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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048453
Receipt No. R000055218
Scientific Title Casecontrol studies:Investigation of the relationship between substances derived from intestinal bacteria and allergic diseases, and development of basic control technologies
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/25

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Basic information
Public title Casecontrol studies:Investigation of the relationship between substances derived from intestinal bacteria and allergic diseases, and development of basic control technologies
Acronym Casecontrol studies:Investigation of the relationship between substances derived from intestinal bacteria and allergic diseases, and development of basic control technologies
Scientific Title Casecontrol studies:Investigation of the relationship between substances derived from intestinal bacteria and allergic diseases, and development of basic control technologies
Scientific Title:Acronym Casecontrol studies:Investigation of the relationship between substances derived from intestinal bacteria and allergic diseases, and development of basic control technologies
Region
Japan

Condition
Condition Asthma, atopic dermatitis, urticaria
Classification by specialty
Pneumology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine whether substances derived from intestinal bacteria are involved in the development or exacerbation of allergic diseases
Basic objectives2 Others
Basic objectives -Others Elucidation of the relationship between allergies and intestinal bacteria
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluate the relationship between components collected from blood and substances derived from intestinal bacteria.
Key secondary outcomes

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Those with allergic diseases (asthma, atopic dermatitis, urticaria)
2 Adults over 18 years of age
3 Gender is not required
4 Those who go to the outpatient clinic
5 Those who, after receiving sufficient explanations for participating in this research, obtain written consent of the research subject of their own free will after sufficient understanding.
Key exclusion criteria (1) Those who are involved in other autoimmune diseases other than allergic diseases (asthma, atopic dermatitis, urticaria)
(2) Those who have a history of cancer of the digestive system, or those who are currently receiving treatment or medication for the disease
(3) Those who have digestive disorders such as irritable bowel syndrome and inflammatory bowel disease
(4) Those who have taken or continued to use antibacterial drugs within 3 months before the explanation of consent
(5) Those who suffer from serious cerebrovascular disease, heart disease, liver disease, kidney disease, digestive disorder, infectious disease that requires notification, etc.
(6) Those who have a history of major surgery on the digestive system, such as gastrectomy, gastrointestinal sutures, intestinal resection, etc.
(7) Those who have significant abnormalities in blood pressure measurement, anthropometry, and blood test
(8) Lactating women, pregnant women, or anyone who may be pregnant
(9) Other persons who are judged by the Principal Investigator to be inappropriate as Research Subjects
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Dai
Middle name
Last name Ishikawa
Organization Juntendo University Hospital
Division name Gastroenterology
Zip code 113-0033
Address 3-1-3 Hongo,Bunkyo-ku,Tokyo
TEL 03-3813-3111
Email dai@juntendo.ac.jp

Public contact
Name of contact person
1st name Takafumi
Middle name
Last name Maruyama
Organization Juntendo University Hospital
Division name Gastroenterology
Zip code 113-0033
Address 3-1-3 Hongo,Bunkyo-ku,Tokyo
TEL 03-3813-3111
Homepage URL
Email t-maruyama@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Metagen Therapeutics, Inc
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kanagawa Institute of Industrial Science and Technology
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University
Address 3-1-3 Hongo,Bunkyo-ku,Tokyo
Tel 03-3814-5672
Email hongo-rinri@juntendo.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
2022 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2022 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2022 Year 08 Month 01 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 No special mention

Management information
Registered date
2022 Year 07 Month 25 Day
Last modified on
2022 Year 07 Month 25 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055218

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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