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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042309 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Rheumatoid Arthritis | |
Classification by specialty |
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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 | |
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Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 50 |
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Name of lead principal investigator |
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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 |
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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 | |
Institute | Nagasaki University |
Institute | |
Department |
Funding Source | |
Organization | Nagasaki University |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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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 |
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Date of disclosure of the study information |
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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 | |
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Results Delayed | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Other | |
Other related information | This is a single-center observational study. |
Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048291 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |