A Pilot Study to Evaluate the Efficacy and Safety of Lactobacillus Species Suppositories on Vaginal Health and pH

Inclusion Criteria:

1. Non-pregnant, non-breastfeeding females between the ages of 40 and 65 years,inclusive.
2. Participants having at least 3 out of following symptoms or signs:
3. Homogeneous, thin, white discharge that smoothly coats the vaginal walls.
4. Presence of the clue cells on microscopic examination (as assessed by wet mounttest)
5. pH of vaginal fluid ≥5
6. A fishy odor of vaginal discharge.
7. Participants with Nugent score of ≥ 7.
8. Participants with a total Vaginal Health Index (VHI) score <15.
9. Participants with pH ≥ 5.
10. Willing to abstain from sexual intercourse 48 hours prior to scheduled clinic visit.
11. Participants able to comply with and perform the procedures requested by the protocol (including IP compliance, blood sample collection procedures and study visitschedule).
12. Participants who are literate enough to understand the essence of study, are informedabout the purpose of the study, and understand their rights.
13. Participants able to give written informed consent and willingness to participate inthe study and comply with its procedures.

Exclusion Criteria:

1. Participants with signs or symptoms of vaginal or cervical or pelvic or urinaryinfection on screening or clinical diagnosis of vaginal/cervical/pelvic/ urinaryinfection in the past 14 days (including but not limited to yeast vulvovaginitis,chlamydia, gonorrhea, trichomonas, genital ulcer disease, pelvic inflammatorydisease).
2. Participants who are undergoing Hormone Replacement Therapy (HRT).
3. Participants on prebiotics or probiotics in the last 1 month.
4. Participants who are currently using antibiotics.
5. Participants with history/ signs of cervical or vaginal high grade squamousintraepithelial dysplasia (HSIL), atypical glandular cells of uncertain significance (AGUS) or cervical intraepithelial neoplasia.
6. Participants who have undergone total hysterectomy or any other surgery involving thefemale reproductive system.
7. Participants who have been diagnosed with polycystic ovary syndrome (PCOS).
8. Uncontrolled type II diabetes mellitus (assessed by RBS ≥140 mg/dL.)
9. Use of an immunosuppressive or immunomodulatory drug within 6 months prior toenrolment.
10. Participants with uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg).
11. Abnormal Thyroid Stimulating Hormone (TSH) value out of reference range of 0.35 to 5.00 μIU/mL.
12. History of any significant neurological and psychiatric condition which may affect theparticipation and inference of the study's end points.
13. Participation in other clinical trials in last 3 months prior to screening.
14. Smokers (Past smokers can be allowed if they have abstinence for minimum 2 years).
15. Chronic or sporadic abdominal pain including moderate to severe dysmenorrhoea.
16. Substance abuse problems (within 2 years) defined as:
17. Use of recreational drugs (such as cocaine, methamphetamine, marijuana,etc.)/Nicotine dependence.
18. High-risk drinking as defined by consumption of 4 or more alcohol containingbeverages on any day or 8 or more alcohol containing beverages per week forwomen.
19. Any of the following clinically significant illness, i.e. Cardiovascular, endocrinesystem, immune system, respiratory system, hepatobiliary system, kidney and urinarysystem, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors,gastrointestinal diseases, etc.
20. History of hepatitis B/ hepatitis C/ HIV infection.
21. Regular medical treatment including over the counter medication, which may have impacton the study aims (e.g., probiotics, antibiotic drugs, laxatives etc.)
22. Any condition that could, in the opinion of the investigator, preclude theparticipant's ability to successfully and safely complete the study or that mayconfound study outcomes.