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Effects of consumption of the test food on the oral environment in healthy subjects

Effects of consumption of the test food on the oral environment in healthy subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on the oral environment in healthy subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048609
Enrollment
30
Registered
2022-08-05
Start date
2022-08-05
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

Healthy Japanese subjects

Interventions

Duration: Two weeks Test food: Lactic acid bacteria and yeast-chewable tablet (yogurt flavor) Administration: Take one tablet twice per day within 3-5 minutes (as long as possible) without chewing r

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic Medical Corporation Yuseikai, Horiuchi Dental Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects who are concerned about their halitosis 6. Subjects who are concerned about their oral sticky 7. Subjects who are concerned about their oral dryness 8. Subjects whose measurement value of halitosis is relatively high

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant during this trial 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in this study by the physician 11. Subjects who use artificial tooth, post crowns, dentures, implants or bridges 12. Subjects who regularly use gargle medicine or mouthwash 13. Subjects who have a medical history or current history of Sjogren's syndrome, or who are suspected it 14. Subjects who have diseases associated with salivary gland such as dry mouse and salivary stone disease 15. Subjects who are undergoing medical treatment for periodontosis or dental caries 16. Subjects who are dental treatment or have dental diseases 17. Subjects who are smokers, or started smoking cessation within one year before the agreement to participate in this trial

Design outcomes

Primary

MeasureTime frame
1. The measurement value of halitosis {brilliant breath (B/B) value in B/B checker}

Secondary

MeasureTime frame
1. Subjective symptom measured by visual analogue scale (an original questionnaire) 2. The volume of saliva

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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