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Completed

NCT Number: NCT06486103

A Clinical Study to Determine the Safety and Efficacy of an Oral Probiotic Supplementation to Improve Bacterial Vaginosis in Females

A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Enhancing Vaginal Health in Females with Mild to Moderate Bacterial Vaginosis: An Open-Label, Single-Arm, Prospective Interventional Proof-of-Science Study.

Total 14 healthy female patients aged 18 to 55 years with mild to moderate bacterial vaginosis will be enrolled to ensure 12 subjects complete the study.

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, 382481, India

About this study

Potential subjects will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent. The subject recruitment department will contact the potential subjects via telephone before the enrolment visit to confirm their participation.

Subjects shall be instructed to visit the facility for the following scheduled visits:

  • Visit 01 [Day 01]: Screening, baseline evaluations, enrolment and test treatment dispensing.
  • Visit 02 [Day 15 (±2 days)]: Treatment Phase, Follow-up Evaluations.
  • Visit 03 [Day 30 (±2 days)]: Treatment End, Final Evaluations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is a healthy non-pregnant/non-lactating females aged 18 to 55 years.
  • Subjects having refrigerator at their home for storage of test treatment.
  • Presence of bacterial vaginosis (BV) as determined by gynaecological examination, including assessment for clinical symptoms such as abnormal vaginal discharge, malodour (moderate to very intense), and other relevant clinical indicators.
  • The subject is willing to provide written informed consent and follow study procedures.
  • The subject is willing to abide by the study protocol and restrictions, including abstaining from using any other intimate wash, lubricant, or treats during the study.
  • The subject is willing to use a highly effective method of contraception throughout the clinical investigation. This includes:
  • Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
  • Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, and agree to continue using the same contraception for the study duration.
  • Agreement for gynaecological pelvic examination by a Gynaecologist.
  • The subject is willing to abstain from sexual intercourse for a period of 24 hours before scheduled study visits to minimize potential interference with study assessments and measurements.

Exclusion criteria

  • The subject has used hormone replacement therapy in the last 3 months.
  • The subject has a history or visible evidence of chronic skin disease or regional infections, genital herpes, vaginal infections, or urinary tract infections.
  • The subject is pregnant/lactating, or are likely to become pregnant.
  • The subject has been diagnosed with or reported gynaecologic abnormalities within 60 days prior to study initiation that may influence study results.
  • The subject has severe systemic complications of viral infections, cardiovascular disorders, neurological disorders, renal disorders, or autoimmune disorders.
  • The subject has chronic infection/allergy/disease that may influence study results.
  • The subject has participated in clinical studies or received any investigational agent in the previous 30 days.
  • The subject has failed to satisfy the Investigator for fitness to participate for any other reason.
  • The subject has not experienced previous episodes of vaginal bleeding of unknown origin within the last 6 months of the screening visit.
  • The subject does not have vaginal prolapse and/or other medical conditions interfering with study conduct and participation.
  • The subject has not used systemic and/or local hormonal products for vaginal dryness or any other vaginal condition in the 3 months prior to screening

Treatment and study plan

MetSheFlora - Vaginal Health

Other

Take one slow-release capsule twice a day, after meal.

Primary outcomes

  1. Change in quality of vaginal discharge

    Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days)

    Assessment of the effectiveness of test treatment in terms of change in quality of vaginal discharge using 5 point scoring scale where 0 indicate absent and 4 indicates very intense

  2. change in odour of vaginal discharge.

    Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days)

    Assessment of the effectiveness of test treatment in terms of change in odour of vaginal discharge using 5 point scoring scale where 0 indicate absent and 4 indicates very intense.

  3. Nugent score

    Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).

    Assessment of the effectiveness of test treatment in terms of change in Nugent score where 0-3 indicates normal, 4-6 indicates intermediate bacterial count and 7-10 indicates bacterial vaginosis.

Secondary outcomes

  1. Change in vaginal pH

    Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days),

    Assessment of the effectiveness of test treatment in terms of change in vaginal pH

  2. Change in VAS score

    Time frame: On Day 01 (before application) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days).

    Assessment of the effectiveness of test treatment in terms of change in VAS score for vaginal itching where 0= indicates no itch and 10 indicates severe itch

  3. Subject's perception

    Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.

    Assessment of the subject's perception regarding the test treatment using a hedonic scale questionnaire for parameters such as smell, taste, overall palatability, perceived effectiveness.

  4. Treatment-emergent adverse events (burning).

    Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.

    Assessment of safety of test treatment through treatment-emergent adverse events such as burning.

  5. Treatment-emergent adverse events (stinging).

    Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.

    Assessment of safety of test treatment through treatment-emergent adverse events such as stinging using scoring scale 0= Indicate absent and 3= severe

  6. Treatment-emergent adverse events (moisture).

    Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.

    Assessment of safety of test treatment through treatment-emergent adverse events such as moisture using scoring scale 0= Indicate absent and 3= severe

  7. Treatment-emergent adverse events (flaking).

    Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.

    Assessment of safety of test treatment through treatment-emergent adverse events such as flaking using scoring scale 0= Indicate absent and 3= severe

  8. Treatment-emergent adverse events (epithelial mucosa).

    Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.

    Assessment of safety of test treatment through treatment-emergent adverse events such as epithelial mucosa using scoring scale 0= Indicate absent and 3= severe

  9. Treatment-emergent adverse events (redness).

    Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.

    Assessment of safety of test treatment through treatment-emergent adverse events such as redness using scoring scale 0= Indicate absent and 3= severe

  10. Treatment-emergent adverse events (dryness).

    Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.

    Assessment of safety of test treatment through treatment-emergent adverse events such as dryness.

  11. Treatment-emergent adverse events (odour).

    Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.

    Assessment of safety of test treatment through treatment-emergent adverse events such as odour using scoring scale 0= Indicate absent and 3= severe

  12. Treatment-emergent adverse events (itching).

    Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.

    Assessment of safety of test treatment through treatment-emergent adverse events such as itching using scoring scale 0= Indicate absent and 3= severe

  13. Treatment-emergent adverse events (soreness of vulva ).

    Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.

    Assessment of safety of test treatment through treatment-emergent adverse events such as soreness of vulva using scoring scale 0= Indicate absent and 3= severe

  14. Safety laboratory tests including Haemoglobin

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Haemoglobin

  15. Safety laboratory tests including Haematocrit

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Haematocrit

  16. Safety laboratory tests including RBC count

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including RBC count

  17. Safety laboratory tests including packed cell volume

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including packed cell volume

  18. Safety laboratory tests including RBC morphology

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including RBC morphology

  19. Safety laboratory tests including mean corpuscular volume

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including mean corpuscular volume

  20. Safety laboratory tests including mean corpuscular hemoglobin

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including mean corpuscular hemoglobin

  21. Safety laboratory tests including mean corpuscular haemoglobin concentration

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including mean corpuscular haemoglobin concentration

  22. Safety laboratory tests including Red blood cell distribution width

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Red blood cell distribution width

  23. Safety laboratory tests including Neutrophils

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Neutrophils

  24. Safety laboratory tests including CBC (Lymphocytes)

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Lymphocytes

  25. Safety laboratory tests including Eosinophils

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Eosinophils

  26. Safety laboratory tests including Monocyte

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Monocyte

  27. Safety laboratory tests including Basophils

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Basophils

  28. Safety laboratory tests including Platelet count

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Platelet count

  29. Safety laboratory tests including mean platelet volume

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including mean platelet volume

  30. Safety laboratory tests including plateletcrit

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including plateletcrit

  31. Safety laboratory tests including Platelet Distribution Width

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Platelet Distribution Width

  32. Safety laboratory tests including random blood sugar

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including random blood sugar

  33. Safety laboratory tests including Total serum cholesterol

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Total serum cholesterol

  34. Safety laboratory tests including CBC (triglyceride)

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including triglyceride

  35. Safety laboratory tests including high-density lipoprotein

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including high-density lipoprotein

  36. Safety laboratory tests including low-density lipoprotein

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including low-density lipoprotein

  37. Safety laboratory tests including CBC (Serum Creatinine)

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Serum Creatinine

  38. Safety laboratory tests including Urinalysis

    Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose

    Assessment of safety of test treatment through the performance of safety laboratory tests including Urinalysis

Sponsors and collaborators

Lead sponsor

NovoBliss Research Pvt Ltd

Other

Collaborators

  • Meteoric Biopharmaceuticals Pvt. Ltd.

Registry information

Official study title

A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Enhancing Vaginal Health in Females with Mild to Moderate Bacterial Vaginosis: an Open-Label, Single-Arm, Prospective Interventional Proof-of-Science Study.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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