Health Condition 1: N760- Acute vaginitis
Conditions
Interventions
Intervention1: Probiotic Supplement: -Total daily dose 50 billion CFU/day (Test arm only)
-fixed duration of 90 consecutive days.
-The route of administration will be oral.
-Dose: 1 capsule twice dail
Sponsors
AceOne Rs
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female participants aged 19 to 50 years 2. Clinical diagnosis of bacterial vaginosis confirmed by Nugent scoring with a score of 4 to 6, preferably 5 to 6, at screening 3. Experiencing symptoms of vaginal dysbiosis such as abnormal discharge odor pain burning sensation irritation or dysuria 4. Ability and willingness to provide written informed consent prior to any study specific procedures 5. Willingness and ability to comply with study procedures including scheduled visits sample collection and study product administration 6. Willingness to avoid non-study products or medications targeting vaginal or urinary tract health throughout the study period
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial within the preceding 3 months 2. History of recurrent urinary tract infections defined as two or more infections within six months or three or more infections within 12 months 3. Regular use of antibiotics antibacterial agents steroids or immunosuppressants 4. Use of products or medications targeting vaginal or urinary tract health within the 12 weeks prior to screening 5. Use of non-study vaginal products such as vaginal moisturizers vaginal estrogen douches or soaps applied intravaginally during the study period 6. Pregnancy lactation or intention to conceive during the study period 7. Known hypersensitivity or allergy to any component of the study product 8. Current or recent history of significant systemic illnesses including but not limited to cardiovascular immune respiratory gastrointestinal liver biliary renal urinary nervous system musculoskeletal psychiatric disorders malignancies or active vaginal or urinary tract infections bleeding or abnormalities unrelated to bacterial vaginosis 9. Diagnosed vaginal or pelvic conditions 10. Use of vaginal-related birth control devices including intrauterine devices or vaginal rings 11. Uncontrolled hypertension defined as systolic greater than or equal to 160 mmHg or diastolic greater than or equal to 100 mmHg 12. Uncontrolled diabetes defined as HbA1c greater than 6 point 5 percent 13. Laboratory abnormalities outside normal reference ranges considered clinically significant by the Principal Investigator including creatinine liver function tests AST ALT and thyroid stimulating hormone 14. Participation in or receipt of acupuncture or other vaginal treatments for vaginal health within one week of screening 15. Current or recent history of smoking or substance abuse within six months 16. Participants who in the opinion of the Principal Investigator are unsuitable for participation due to medical safety or compliance considerations that may interfere with study assessments or endpoints
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Nugent score Definition Difference in Nugent score on a 0 to 10 scale from baseline Day 0 to end of treatment Day 90 Assessment Method Gram stained vaginal smear evaluated by a trained microbiologist Time Points Day 0 baseline Day 30 Day 60 and Day 90 Success Criterion Significant increase in Lactobacillus dominated microbiota with Nugent score less than or equal to 3 compared to baseline 2. Increase in beneficial vaginal bacteria specifically Lactobacillus species Definition Quantitative change in Lactobacillus species DNA copies per milliliter in vaginal samples Assessment Method Quantitative PCR targeting L helveticus and other beneficial species Time Points Day 0 and Day 90 Success Criterion Statistically significant increase in beneficial lactobacilli compared to baseline and placeboTimepoint: Visit 1 (Day 0) Visit 2 (Day 30 2 days) Visit 3 (Day 60 2 days) Visit 4 (Day 90 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| The study will evaluate the safety and effectiveness of probiotics in women with bacterial vaginosis. Key outcomes include changes in Nugent score and levels of beneficial Lactobacillus species in vaginal samples. The study will also assess reduction in harmful bacteria, vaginal pH, and vulvovaginal symptoms such as discharge odor burning and dysuria. Safety and tolerability will be monitored through adverse events, vital signs, and laboratory tests. Assessments will occur at baseline and multiple time points during the 90-day study period. The results will provide evidence on whether the probiotic is safe and helps restore a healthy vaginal microbiota.Timepoint: Visit 1 (Day 0) Visit 2 (Day 30 2 days) Visit 3 (Day 60 2 days) Visit 4 (Day 90 2 days) | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
SAMAHITHA RESEARCH SOLUTIONS
Outcome results
None listed