UMIN-CTR Clinical Trial

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

Cerebrovascular disease

Classification by specialty

Neurology

Dental medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Division of Neurology, Department of Stroke and Cerebrovascular Diseases

Institute

Department

Personal name

Organization

Mitsui Sumitomo Insurance Welfare Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Division of Oral Infection and Disease Control, Osaka University Graduate School of Dentistry.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立循環器病研究センター（大阪府）

Date of disclosure of the study information

2016

Year

07

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2016

Year

07

Month

20

Day

Last modified on

2016

Year

07

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026747