UMIN-CTR Clinical Trial

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
Last 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
1st 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