Overview

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

Status:
Not yet recruiting
Trial end date:
2022-08-12
Target enrollment:
0
Participant gender:
Female
Summary
Most of the methods involved in the treatment of BV include antibiotics. Some of the antibiotics used for this include metronidazole, clindamycin and fluconazole. The antibiotics inhibit the growth of anaerobes that support G. vaginalis and other microbes without affecting lactobacilli. This leads to the treatment of BV while also preventing its recurrence. However, the use of antibiotics may lead to antibiotic resistance and cause various side-effects such as thrush, dizziness, rash, nausea, etc. In the case of many antibiotics, the cure rates were incredibly poor and the BV recurrence rates reached as high as 80 %. Probiotic therapy has slowly been replacing antibiotics for the treatment and prevention of BV and other infections. These probiotics usually contain lactobacilli and help maintain a healthy vaginal environment. They can either be consumed through curd and other milk products that contain probiotics (mostly lactobacilli) or they can be used in the form of suppositories that are placed in the vagina. In probiotics containing lactobacilli, the lactic acid produced by the bacteria lowers the vaginal pH to the ideal range of 3.5 to 4.5 and prevents infection recurrence. Lactobacilli containing suppositories have been successfully used in the past to treat BV, being marketed as a safe and effective way to prevent and treat infections for women in various stages of their lives.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Criteria
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:

1. Homogeneous, thin, white discharge that smoothly coats the vaginal walls.

2. Presence of the clue cells on microscopic examination (as assessed by wet mount
test)

3. pH of vaginal fluid ≥5

4. A fishy odor of vaginal discharge.

3. Participants with Nugent score of ≥ 7.

4. Participants with a total Vaginal Health Index (VHI) score <15.

5. Participants with pH ≥ 5.

6. Willing to abstain from sexual intercourse 48 hours prior to scheduled clinic visit.

7. Participants able to comply with and perform the procedures requested by the protocol
(including IP compliance, blood sample collection procedures and study visit
schedule).

8. Participants who are literate enough to understand the essence of study, are informed
about the purpose of the study, and understand their rights.

9. Participants able to give written informed consent and willingness to participate in
the study and comply with its procedures.

Exclusion Criteria:

1. Participants with signs or symptoms of vaginal or cervical or pelvic or urinary
infection on screening or clinical diagnosis of vaginal/cervical/pelvic/ urinary
infection in the past 14 days (including but not limited to yeast vulvovaginitis,
chlamydia, gonorrhea, trichomonas, genital ulcer disease, pelvic inflammatory
disease).

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 squamous
intraepithelial 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 the
female 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 to
enrolment.

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 the
participation 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:

1. Use of recreational drugs (such as cocaine, methamphetamine, marijuana,
etc.)/Nicotine dependence.

2. High-risk drinking as defined by consumption of 4 or more alcohol containing
beverages on any day or 8 or more alcohol containing beverages per week for
women.

17. Any of the following clinically significant illness, i.e. Cardiovascular, endocrine
system, immune system, respiratory system, hepatobiliary system, kidney and urinary
system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors,
gastrointestinal diseases, etc.

18. History of hepatitis B/ hepatitis C/ HIV infection.

19. Regular medical treatment including over the counter medication, which may have impact
on the study aims (e.g., probiotics, antibiotic drugs, laxatives etc.)

20. Any condition that could, in the opinion of the investigator, preclude the
participant's ability to successfully and safely complete the study or that may
confound study outcomes.