Unique ID issued by UMIN | UMIN000029105 |
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Receipt number | 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 | 2022/07/19 16:51:09 |
he study to confirm the safety of excessive intake of a food containing lactic acid bacteria for improvement of oral health: An open trial
The study to confirm the safety of excessive intake of a food containing lactic acid bacteria for improvement of oral health
he study to confirm the safety of excessive intake of a food containing lactic acid bacteria for improvement of oral health: An open trial
The study to confirm the safety of excessive intake of a food containing lactic acid bacteria for improvement of oral health
Japan |
None (Healthy adults)
Adult |
Others
NO
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
Safety
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Ingest the yogurt drink containing lactic acid bacteria LH strain for 4 weeks
20 | years-old | <= |
65 | years-old | >= |
Male and Female
(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.
(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.
20
1st name | |
Middle name | |
Last name | Tatsuo Yanagisawa |
Yanagisawa Dental Office
Director
8F Mishina Building, 1-18-1, Minamiikebukuro, Toshima-ku, Tokyo, 171-0022, Japan
03-3982-4790
varitudo@kpe.biglobe.ne.jp
1st name | |
Middle name | |
Last name | Eiji Yoshikawa |
KSO Corporation
Sales department
7F Shibaura Omodaka Bldg, 1-9-7 Shibaura, Minato-ku, Tokyo, 105-0023, Japan
03-3452-7733
yoshikawa@kso.co.jp
KSO Corporation
MEGMILK SNOW BRAND Co., Ltd.
Profit organization
NO
柳澤デンタルオフィス(東京都)/ Yanagisawa Dental Office (Tokyo)
2018 | Year | 11 | Month | 18 | Day |
Unpublished
Completed
2017 | Year | 09 | Month | 14 | Day |
2017 | Year | 09 | Month | 14 | Day |
2017 | Year | 09 | Month | 29 | Day |
2017 | Year | 12 | Month | 28 | Day |
2017 | Year | 09 | Month | 12 | Day |
2022 | Year | 07 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033287
Research Plan | |
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