UMIN-CTR Clinical Trial

Basic information
Public title	An association study of intestinal bacteria with peripheral Th cell responses
Acronym	An association study of gut metagenomics and Th cell responses
Scientific Title	An association study of intestinal bacteria with peripheral Th cell responses
Scientific Title:Acronym	An association study of gut metagenomics and Th cell responses
Region	Japan

Condition
Condition	Rheumatoid arthritis, Behcet's disease, SLE
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We hypothesize that changed composition and function of gut bacteria activate T cells and are related to the disease aggravation. We compare metagenomics data with T cell responces.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To develop a new analysis of the pathogenesis of autoimmune diseases
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	Patients fulfilled the diagnostic criteria proposed by ACR/EULAR. (Rheumatoid arthritis) Patients fulfilled the diagnostic criteria proposed by the International Study Group. (Behcet's Disease) Patients fulfilled the diagnostic criteria proposed by ACR. (SLE)
Key exclusion criteria	None
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Shimizu
Organization	St. Marianna University School of Medicine
Division name	Department of Immunology and Medicine
Zip code	216-8511
Address	Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
TEL	044-977-8111
Email	jshimizu@marianna-u.ac.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Shimizu
Organization	St. Marianna University School of Medicine
Division name	Department of Immunology and Medicine
Zip code	216-8511
Address	Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
TEL	044-977-8111
Homepage URL
Email	jshimizu@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	MEXT (Japan)
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	St. Marianna University School of Medicine
Address	Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
Tel	044-977-8111
Email	k-sienbu.mail@marianna-u.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	2015 Year 09 Month 08 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	Open public recruiting
Date of protocol fixation	2013 Year 11 Month 20 Day
Date of IRB	2013 Year 11 Month 20 Day
Anticipated trial start date	2015 Year 09 Month 08 Day
Last follow-up date	2035 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We analyzed the data of 12 patients and 12 normal individuals. We submitted the data now.

Management information
Registered date	2015 Year 09 Month 08 Day
Last modified on	2020 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021913