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 |
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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
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
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
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
