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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029105
Receipt No. R000033287
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
Date of disclosure of the study information 2018/11/18
Last modified on 2017/09/12

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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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 29 Day
Last follow-up date
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
2017 Year 09 Month 12 Day


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

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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