UMIN-CTR Clinical Trial

Basic information
Public title	he study to confirm the safety of excessive intake of a food containing lactic acid bacteria for improvement of oral health: An open trial
Acronym	The study to confirm the safety of excessive intake of a food containing lactic acid bacteria for improvement of oral health
Scientific Title	he study to confirm the safety of excessive intake of a food containing lactic acid bacteria for improvement of oral health: An open trial
Scientific Title:Acronym	The study to confirm the safety of excessive intake of a food containing lactic acid bacteria for improvement of oral health
Region	Japan

Condition
Condition	None (Healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to confirm the safety of the excess intake of a food containing lactic acid bacteria that improve oral health
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Interview (subjective symptom) Gingival index Plaque index Periodontal index Oral mucosa Staining of tooth Saliva secretion Saliva pH General clinical examination Hematologic test: White blood cell count, Red blood cell count, Hemoglobin, Hematocrit, Platelet count, MCV, MCH, MCHC Biochemical analysis: Total protein, Albumin, A/G, AST (GOT), ALT (GPT), LD (LDH), Total bilirubin, ALP, gamma-GTP, Urea nitrogen (UN), Creatinine, Uric acid (UA), Sodium, Potassium, Chlorine, Calcium, Magnesium, Total cholesterol, LDL-cholesterol, TG (triglyceride), fasting glucose Urine test: Protein, Glucose, Urobilinogen, Bilirubin, pH, Specific gravity, Ketone, and Blood Blood pressure/pulse
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	Prevention
Type of intervention	Food
Interventions/Control_1	Ingest the yogurt drink containing lactic acid bacteria LH strain for 4 weeks
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Subjects aged between 20 to 65 years old. (2) Subjects who generally take three meals a day. (3) Subjects who have no oral problem or have mild problems. (4) Subject who have more than four teeth possible to examine out of the lavial-buccal side of the six teeth including maxillary right first molar (FDI tooth number 16), maxillary left central incisor (21), maxillary left first premolar (24), mandibular left first molar (36), mandibular right central incisor (41), and mandibular right first premolar (44). Instead of the subjects as mentioned above, subjects having FDI number 17, 15, 11, 22, 25, 37, 35, 31, 42, and 45 are also applicable. (5) Subjects who are not receiving treatment for caries and periodontal disease, and have at least 20 teeth now. (6) Subjects who received a sufficient explanation of the purpose and contents of this examination, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.
Key exclusion criteria	(1) Subject who are diagnosed with caries (C3 or more) or severe periodontal disease. (2) Subject who have illness such as diabetes, chronic kidney disease, gastrointestinal disease, lung disease, malignant tumor and so on, and are taking medicine. (3) Subjects who are using products that have halitosis preventing effect such as mouse washes daily. (4) Subjects who have gastrointestinal disease or history of gastrointestinal surgery that may affect digestion and absorption. (5) Subject whose saliva secretion by stimulation during 5 minute is less than 3.0 mL. (6) Subjects whose pH of saliva is 6.2 or less. (7) Subjects who are taking antibiotics and/or anti-microbe agents, or who had taken them within one month prior to the screening test. (8) Subjects who have food allergy, lactose intolerance, and/or feeling of unwellness by the dairy products. (9) Subjects who are wearing removal dentures. (10) Subjects who are pregnant, or who are planning to become pregnant or breast-feeding during the test. (11) Persons who are participating or intend to participate in other tests for taking foods, drugs, and/or cosmetics. (12) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tatsuo Yanagisawa
Organization	Yanagisawa Dental Office
Division name	Director
Zip code
Address	8F Mishina Building, 1-18-1, Minamiikebukuro, Toshima-ku, Tokyo, 171-0022, Japan
TEL	03-3982-4790
Email	varitudo@kpe.biglobe.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code
Address	7F Shibaura Omodaka Bldg, 1-9-7 Shibaura, Minato-ku, Tokyo, 105-0023, Japan
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	MEGMILK SNOW BRAND Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	柳澤デンタルオフィス（東京都）/ Yanagisawa Dental Office (Tokyo)

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 18 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	Completed
Date of protocol fixation	2017 Year 09 Month 14 Day
Date of IRB	2017 Year 09 Month 14 Day
Anticipated trial start date	2017 Year 09 Month 29 Day
Last follow-up date	2017 Year 12 Month 28 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 09 Month 12 Day
Last modified on	2022 Year 07 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033287