Bacterial vaginosis and candidal vaginosis Bacterial vaginosis and candidal vaginosis
Conditions
Interventions
Self-insertion of capsul containing lactobacillus into the vagina
Sponsors
Kondo Eiji
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Target disease: Patients with vaginitis-like symptoms suspected of bacterial vaginosis or candidal vaginitis 2) Age: Women aged 18 years or older and 45 years or younger 3) General condition: Subjects experiencing itching in the vulva or vagina 4) Written consent: Subjects must provide written consent
Exclusion criteria
Exclusion criteria: 1) Subjects suspected of having bacterial vaginosis or candidal vaginitis within one month prior to the start of study drug administration. 2) Subjects who have received drug treatment or have taken probiotics or other preparations or supplements similar to the study drug for the above conditions. 3) Subjects diagnosed with atrophic vaginitis. 4) Subjects with allergies to treatment medications. 5) Subjects who are pregnant or whose pregnancy cannot be ruled out. 6) Subjects who have participated in other clinical trials (clinical studies) that could improve bacterial vaginosis or candidal vaginitis within one month of starting study drug administration. 7) Subjects currently receiving treatment for malignant tumors or hematologic malignancies. 8) Subjects currently receiving immunosuppressant medications or corticosteroid therapy. 9) Subjects deemed inappropriate for participation by the principal investigator or co-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement Rate of Vaginal Lactobacillus The FloraSelect test scores vaginal Lactobacillus occupancy on a four-point scale: Below detection (0), Low (1), Medium (2), and High (3). The difference in score before and after intervention was calculated as (post-intervention score - pre-intervention score), with subjects with a difference in score of +1 or greater defined as "improved." Subjects with a difference in score of 0 were defined as "unchanged," while subjects with a difference in score of -1 or less were defined as "worsened." For the calculation of the primary endpoint, improvement rate, unchanged and worsened outcomes were treated as "non-improved." The denominator for the primary analysis was the evaluable population, which included subjects for whom both pre- and post-intervention scores were available. Improvement rate (%) = (Number of subjects with difference in score >= +1 / Number of evaluable subjects) x 100 Note that in subjects with a high baseline score (3), improvement due to an increase in the baseline score may be difficult to detect due to a ceiling effect. Therefore, clinical efficacy in this population should be evaluated and interpreted based on the change in the symptom index (VSQ), which is a secondary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in vaginal Lactobacillus score: (post-intervention score - pre-intervention score) 2. difference in score in the population excluding subjects whose pre-intervention score was High (3) and maintained that score after the intervention. 3. Detection rate of each BV or VVC-associated bacteria (Gardnerella, Prevotella, Streptococcus, Atopobium, Ureaplasma, Mycoplasma) in FloraSelect: Detection rate = (number of subjects with detected bacteria / number of evaluable subjects) x 100 4. Change in detection rate of each BV or VVC-associated bacteria in FloraSelect: Detection rate after intervention - Detection rate before intervention 5. Recovery rate to a Lactobacillus-dominant flora: Recovery rate = (number of subjects who achieved a Medium (2) or High (3) score after the intervention / number of evaluable subjects whose pre-intervention score was not High (3)) x 100 6. Change in VSQ score: ( post-intervention score - pre-intervention score) 7. VSQ score improvement rate: Improvement rate = (number of subjects whose VSQ score decreased from pre-intervention /number of evaluable subjects) x 100 8. Positive agreement rate with vaginal culture test (compared to FloraSelect): Positive agreement rate = (number of subjects in which the same bacterial species were detected by both tests number of subjects evaluable for both tests) x 100 | — |
Contacts
Public ContactMoeko Kuriyama
Mie University Hospital
Outcome results
None listed