Clinical Study to evaluate the Efficacy and Safety of Lactobacillus Probiotic Suppositories on Vaginal Health and pH.

Not Applicable

Completed

• Registration Number: CTRI/2022/01/039560
• Lead Sponsor: Vedic Lifesciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-06-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 69

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:

2.1 Homogeneous, thin, white discharge that smoothly coats the vaginal walls;

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

2.3 pH of vaginal fluid �5

2.4 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/cervical/pelvic/ 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 �¼IU/mL.

12. History of any significant neurological and psychiatric condition which may affect the participation and inference of the studyââ?¬•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:

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

16.2 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 OTC, 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 participantââ?¬•s ability to successfully and safely complete the study or that may confound study outcomes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Investigational product (IP) on Vaginal pH as assessed by a pH indicator from baseline to Day 28 in comparison to placebo.Timepoint: Day 0 vs Day 28

Secondary Outcome Measures

Name	Time	Method
Microbial infection control as assessed by the Nugent score from baseline to Day 28 in comparison to placeboTimepoint: Day 0 vs Day 7, Day 21 and Day 28;Number of participants who experienced adverse events from baseline in comparison to placeboTimepoint: Day 7, Day 21 and Day 28;Overall Vaginal Health as assessed through clinical examination using the Vaginal Health Index from baseline to Day 28 in comparison to placeboTimepoint: Day 0 and Day 28;Percentage responders as assessed by the number of BV-free women determined using the Nugent score at Day 28 in comparison to placebo.Timepoint: Day 0 and Day 28;Vaginal itching as assessed by Visual Analogue Scale (0-10) from baseline to Day 28 in comparison to placeboTimepoint: Day 0 vs Day 7, Day 21 and Day 28;Vaginal pH as assessed by a pH indicator from baseline to Day 7 and Day 21 in comparison to placebo.Timepoint: Day 0 vs day 7 and Day 21