UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Change of oral bacterial flora and oxidative stress marker in patients with Parkinson disease
Title of the study (Brief title)	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	Masaaki Hirayama
Organization	Nagoya University Graduate School of Medicine
Division name	Department of clinical laboratory
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	Masaaki Hirayama
Organization	Nagoya University Graduate School of Medicine
Division name	Department of clinical laboratory
Address	1-1-20 Daiko-Minami, Higashi-ku, Nagoya, Aichi
TEL	0527441184
Homepage URL
Email	hirasan@met.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 03 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024852