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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023252
Receipt No. R000026747
Scientific Title The effects of oral infectious disease on cerebrovascular disease-an observational study
Date of disclosure of the study information 2016/07/22
Last modified on 2016/07/20

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Basic information
Public title The effects of oral infectious disease on cerebrovascular disease-an observational study
Acronym The relationship between oral infectious disease and cerebrovascular disease
Scientific Title The effects of oral infectious disease on cerebrovascular disease-an observational study
Scientific Title:Acronym The relationship between oral infectious disease and cerebrovascular disease
Region
Japan

Condition
Condition Cerebrovascular disease
Classification by specialty
Neurology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 There is emerging evidence suggesting that human microbiome, especially gut microbiome, largely interact with metabolic processes and immune systems of human. the recent innovation and advent in next generation sequencing had contributed to the analysis of metagenomics of human microbiome. In neurology, Campylobacter jejuni is thought to play a role in Guillan-Barre syndrome, gut microbiome partially influences the effects of therapeutic agent for Parkinson's disease. These findings provide us a new strategy that probiotic products or antibiotics may modify systemic disease Steptococcus mutans (S. mutans) is a common bacteria of oral microbiome known to be a major pathogen for dental caries. Approximately 20% of S. mutans strains possess cnm gene (cnm-positive S. mutans) encoding cell wall anchored surface protein Cnm, a collagen-binding protein. Nakano et al. reported that cnm-positive S. mutans exacerbated cerebral hemorrhage and accumulated in photochemically damaged cerebral blood vessels in stroke model mice. Our human stroke cohort, cnm-positive S. mutans was positive in saliva in 26 percent of patients with intracerebral hemorrhage but only in 6 percent of those with other types of stroke. The number of deep cerebral microbleeds on MRI, surrogate markers of cerebral small vessel disease, was significantly greater in those with cnm-positive S. mutans and correlated with collagen binding activities in each strains.In this study, we aims to research whether cnm-gene positive S. mutans is associated with other cerebrovascular disease, for example, cerebral mayloid angiopathy or intracranial artery aneurysm.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes the possession rate of cnm-gene positive Streptococcus mutans in patients with cerebrovascular disease and assess the MRI surrogate marker, blood test and cognitive function.
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria from September 2016 to March 2016, the patients admitted on National Cerebral and Cardiovascular center and receive written informed consent.
Key exclusion criteria modified Rankin scale of pre-admittion is more than 3 or patients who are apparently difficalt to declare their intension for agreement to join the study because of unconsciousness or cognitive imparment
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi tonomura
Organization National Cerebral and Cardiovascular Center
Division name Division of Neurology, Department of Stroke and Cerebrovascular Diseases
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL 06-6833-5012
Email tono0822shuichi@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shuichi tonomura
Organization National Cerebral and Cardiovascular Center
Division name Division of Neurology, Department of Stroke and Cerebrovascular Diseases
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL 06-6833-5012
Homepage URL
Email tono0822shuichi@gmail.com

Sponsor
Institute Division of Neurology, Department of Stroke and Cerebrovascular Diseases
Institute
Department

Funding Source
Organization Mitsui Sumitomo Insurance Welfare Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Division of Oral Infection and Disease Control, Osaka University Graduate School of Dentistry.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立循環器病研究センター(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 22 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 No longer recruiting
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The types of cerebrovascular disease is defined by TOAST, SMASH-U and modified Boston criteria. Small vessel disease, lacune, white matter hyperintensities and perivascular space are evaluated using 3.0 tesla MRI and Intracranial artery stenosis and aneurysm are evaluated using MRA, CTA or DSA. The nerurological symptom is evaluated by NIHSS, functional outcome is evaluated by mRS and FIM and cognitive function is evaluated by MoCA-J and MMSE.

Management information
Registered date
2016 Year 07 Month 20 Day
Last modified on
2016 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026747

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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