Healthy adults
Conditions
Interventions
Take one capsule of test food with water or warm water once a day.
Take one capsule of placebo food with water or warm water once a day.
Sponsors
IMEQRD Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged between 20 and less than 60 years old at the time obtaining consent. 2. Japanese females. 3. Individuals who can receive vaginal speculum examination on the internal examination table. 4. Individuals who can input electric diaries using smart phones or PCs. 5. Individuals who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals who are diagnosed as bacterial vaginosis in the past 3 months. 2. Individuals who currently are undergoing treatment for any disease, or receive medical treatment such as medical drugs or traditional Chinese medicines. Medications used as needed except antibiotics are acceptable. 3. Individuals whose menstrual cycles are unstable. 4. Individuals who regularly use intestinal regulators involving laxatives. 5. Individuals who received treatments involving oral medicines of antibiotics or Intravenous drip in the past 3 months. 6. Individuals who currently have or past had organic diseases concerning digestive system excluding oral cavity, esophagus, and stomach. 7. Individuals who currently have or past had severe diseases concerning liver, kidney, heart, respiratory system, endocrine, metabolism. 8. Individuals who did vaginal cleansing in the past 3 months. 9. Individuals who use intrauterine contraceptives. 10. Individuals who have currently been taking commercially available drugs, quasi-drug products, foods, or supplements with any functional claims. 11. Individuals who regularly take food mainly compounding lactate acid bacteria involving yogurt or lactic acid bacteria beverage. 12. Individuals who have used public pools containing chlorine, bath, or hot springs in the past 3 months. 13. Individuals who currently have or past had allergies to drugs or foods. 14. Individuals who take more than 60 g alcohol/day. 15. Individuals who are planning to extremely change lifestyle (such as diet, sleep, or exercise) during the study period. 16. Individuals who joined, have been joined, or are planning to join other clinical trials from one month before the trials. 17. Individuals who are currently pregnant or breastfeeding, or planning to pregnant during the study. 18. Individuals who are unsuitable for the study, that judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nugent score | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal Flora pH Questionnaire: QoL, defecation, Vaginal symptoms, pain, irritation, discomfort, feeling, concentration Nugent score: subgroups divided by Nugent score at the screening | — |
Countries
Japan
Contacts
Public ContactHirokuni Kayama
IMEQRD Co., Ltd. Planning and Sales Department
Outcome results
None listed