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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032553
Receipt No. 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

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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
Email 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
Email nb-koriyama@kagomc2.hosp.go.jp

Sponsor
Institute National Hospital Organization Kagoshima Medical Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036821

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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