UMIN-CTR Clinical Trial

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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