UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042309 |
|---|---|
| Receipt number | R000048291 |
| Scientific Title | Analysis of the pathogenic mechanism of rheumatoid arthritis by focusing on the oral microbiome |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2020/11/01 02:20:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of the pathogenic mechanism of rheumatoid arthritis by focusing on the oral microbiome
Acronym
RA-OralMB Study
Scientific Title
Analysis of the pathogenic mechanism of rheumatoid arthritis by focusing on the oral microbiome
Scientific Title:Acronym
RA-OralMB Study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In the two groups of ACPA-positive/negative RA, we focus on environmental factors (oral dysbiosis, periodontal disease, smoking, and HTLV-1 infection) and genetic factors (HLA-SE) that are associated with the production of ACPA to elucidate the mechanism of RA.
Basic objectives2
Others
Basic objectives -Others
To elucidate the pathogenesis of RA, we focused on 1) what environmental factors are associated with ACPA production (oral disbiosis, periodontal disease, smoking, and HTLV-1 infection) 2) what families of microbiome is represented in the oral microbiome of ACPA-positive RA patients and 3) whether ACPA maturation (i.e., elevated ACPA levels and isotype expansion) progresses in a population with HLA-DR shared epitope (SE) in addition to environmental factors.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
difference of oral microbiome composition
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Rheumatoid Arthritis patients
(2) Those who, after receiving a full explanation of their participation in this study, have obtained written consent of their own free will with a full understanding of the research subject.
Key exclusion criteria
(1)Those with no remaining teeth
(2)Others who are deemed unsuitable as research subjects by the attending physician or principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawakami |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences
Zip code
8528501
Address
1-7-1, Sakamoto,Nagasaki-shi,Nagasaki
TEL
0958197200
atsushik@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Tsuji |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences
Zip code
8528501
Address
1-7-1, Sakamoto,Nagasaki-shi,Nagasaki
TEL
0958197200
Homepage URL
yoshikatsuji@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research cencer, Nagasaki univrtsity
Address
1-7-1 Sakamoto
Tel
0958197200
rinshou7726@umin.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
| 2020 | Year | 12 | 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
| 2020 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center observational study.
Management information
Registered date
| 2020 | Year | 11 | Month | 01 | Day |
Last modified on
| 2020 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048291
