UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027352 |
|---|---|
| Receipt number | R000029901 |
| Scientific Title | effect to colon polyps and microbiota by the treatment for periodontitis |
| Date of disclosure of the study information | 2017/05/16 |
| Last modified on | 2019/11/25 19:09:13 |
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Basic information
Public title
effect to colon polyps and microbiota by the treatment for periodontitis
Acronym
association of periodontitis and colon
Scientific Title
effect to colon polyps and microbiota by the treatment for periodontitis
Scientific Title:Acronym
association of periodontitis and colon
Region
| Japan |
Condition
Condition
periodontitis
colon polyps
Classification by specialty
| Hepato-biliary-pancreatic medicine | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To research the effect of treatment for periodontitis to colon polyps and microbiota especially for Fusobacterium nucleatum.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of expression level by PCR for Fusobacterium nucleatum, before and after treatment for periodontitis.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Treatment for periodontitis.
Mainly an intraoral care and medical guidance for daily life.
Expected duration would be 1 to 3 months.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The age is 20 to 80 years-old.
2. Diagnosed with colon polyp and periodontitis.
3. Indipendent to walk and able to answer the questionnaire.
4. Has an agreement to participate the research.
Key exclusion criteria
1. Who refuse the treatment for colon polyp and periodontitis.
2. If the patient is suspected of colorectal cancer.
3. Who received a treatment by antibiotics before treatment for colon polyp. Who takes probiotics regularly.
4. Who is decided to be inadequate by a doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
2360004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city, Kanagawa
TEL
045(787)2640
takumahigurashi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
2360004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city, Kanagawa
TEL
045(787)2640
Homepage URL
takuma_h@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University School of Medicine Clinical Research Promotion Division Ethics Section
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city, Kanagawa
Tel
045-370-7627
t156030@yokohama-cu.ac.jp
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
| 2017 | Year | 05 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 16 | Day |
Last modified on
| 2019 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029901
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
