UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021599
Receipt number R000024852
Scientific Title Change of oral bacterial flora and oxidative stress marker in patients with Parkinson disease
Date of disclosure of the study information 2016/03/25
Last modified on 2016/09/23 20:05:18

* 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

Change of oral bacterial flora and oxidative stress marker in patients with Parkinson disease

Acronym

Change of oralbiomarker in patients with Parkinson disease

Scientific Title

Change of oral bacterial flora and oxidative stress marker in patients with Parkinson disease

Scientific Title:Acronym

Change of oralbiomarker in patients with Parkinson disease

Region

Japan


Condition

Condition

Parkinsonian patients and normal controls (age-matched control)

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Chronic inflammation in gastrointestinal tract is suggested to be involved in the pathogensis of Parkinson disease. In this study, oral inflammation is estimated by use of non-invasive samples such as saliva.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Inflammatory factors and oxidative stress markers in saliva

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

saliva,dental plaque were measured every year.

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) Patients diagnosed as Parkinson disease by the neurologist or their caregiver.
2) Patients with obtained informed consent in writing
3) Patients with age over 20 y.o.

Key exclusion criteria

No specific exclusion criteria

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaaki Hirayama

Organization

Nagoya University Graduate School of Medicine

Division name

Department of clinical laboratory

Zip code


Address

1-1-20 Daiko-Minami, Higashi-ku, Nagoya, Aichi

TEL

0527441184

Email

hirasan@met.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masaaki Hirayama

Organization

Nagoya University Graduate School of Medicine

Division name

Department of clinical laboratory

Zip code


Address

1-1-20 Daiko-Minami, Higashi-ku, Nagoya, Aichi

TEL

0527441184

Homepage URL


Email

hirasan@met.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 25 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

2016 Year 03 Month 23 Day

Date of IRB


Anticipated trial start date

2016 Year 06 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information

Chronic inflammation in gastrointestinal tract is suggested to be involved in the pathogensis of Parkinson disease. In this study, oral inflammation is estimated by use of non-invasive samples such as saliva.


Management information

Registered date

2016 Year 03 Month 24 Day

Last modified on

2016 Year 09 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024852


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name