UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032553 |
|---|---|
| Receipt number | R000036821 |
| Scientific Title | A study on the significance of probiotic treatment for type 2 diabetes patients with periodontal disease |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2019/04/14 16:59:17 |
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Basic information
Public title
A study on the significance of probiotic treatment for type 2 diabetes patients with periodontal disease
Acronym
Probiotic treatment for type 2 diabetes patients with periodontal disease
Scientific Title
A study on the significance of probiotic treatment for type 2 diabetes patients with periodontal disease
Scientific Title:Acronym
Probiotic treatment for type 2 diabetes patients with periodontal disease
Region
| Japan |
Condition
Condition
Type2 diabetes mellitus and periodontal disease
Classification by specialty
| Endocrinology and Metabolism | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish new treatment for periodontal disease and diabetes by confirming the effect of probiotic treatment for periodontal disease and glycemic control. Furthermore, to establish a form of new medical dental cooperation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of Both HbA1c or glycoalbumin and periodontal disease.
Key secondary outcomes
Improvement of TNF-alfa
Improvement of malondialdehyde (MDA)
Improvement of total antioxidant capacity (TAC)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lactomin is administered 4 grams daily for 60 days.
Interventions/Control_2
lactomin is not administered.
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
| 25 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients with HbA1c greater than 7% with periodontal disease combined.
Key exclusion criteria
Patients currently receiving periodontal disease treatment.
Patients who changed or increased oral hypoglycemic drugs within the past 3 month.
Women who are pregnant or breast feeding.
Patients who received diagnosis of malignant tumor within the past year.
Patients who developed cardiovascular events within the past year.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Koriyama |
Organization
National Hospital Organization Kagoshima Medical Center
Division name
The Department of Diabetes and Endocrine Medicine
Zip code
Address
8-1 Shiroyama-chyo, Kagoshima 892-0853
TEL
099-223-1151
nb-koriyama@kagomc2.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Koriyama |
Organization
National Hospital Organization Kagoshima Medical Center
Division name
The Department of Diabetes and Endocrine Medicine
Zip code
Address
8-1 Shiroyama-chyo, Kagoshima 892-0853
TEL
099-223-1151
Homepage URL
nb-koriyama@kagomc2.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kagoshima Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kagoshima Medical Center
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
| 2018 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 11 | Day |
Last modified on
| 2019 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036821
| 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 |
