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he study to confirm the safety of excessive intake of a food containing lactic acid bacteria for improvement of oral health: An open trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029105
Enrollment
20
Registered
2018-11-18
Start date
2017-09-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None (Healthy adults)

Interventions

Ingest the yogurt drink containing lactic acid bacteria LH strain for 4 weeks

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026