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.

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Other: MetSheFlora - Vaginal Health

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmadabad, Gujarat, India, 382481
      • NovoBliss Research Pvt.Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. The subject is a healthy non-pregnant/non-lactating females aged 18 to 55 years.
2. Subjects having refrigerator at their home for storage of test treatment.
3. 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.
4. The subject is willing to provide written informed consent and follow study procedures.
5. 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.

6. The subject is willing to use a highly effective method of contraception throughout the clinical investigation. This includes:

   1. 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).
   2. 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.
7. Agreement for gynaecological pelvic examination by a Gynaecologist.
8. 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:

1. The subject has used hormone replacement therapy in the last 3 months.
2. The subject has a history or visible evidence of chronic skin disease or regional infections, genital herpes, vaginal infections, or urinary tract infections.
3. The subject is pregnant/lactating, or are likely to become pregnant.
4. The subject has been diagnosed with or reported gynaecologic abnormalities within 60 days prior to study initiation that may influence study results.
5. The subject has severe systemic complications of viral infections, cardiovascular disorders, neurological disorders, renal disorders, or autoimmune disorders.
6. The subject has chronic infection/allergy/disease that may influence study results.
7. The subject has participated in clinical studies or received any investigational agent in the previous 30 days.
8. The subject has failed to satisfy the Investigator for fitness to participate for any other reason.
9. The subject has not experienced previous episodes of vaginal bleeding of unknown origin within the last 6 months of the screening visit.
10. The subject does not have vaginal prolapse and/or other medical conditions interfering with study conduct and participation.
11. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bacterial Vaginosis; Take one slow-release capsule twice a day, after meal, orally.	Other: MetSheFlora - Vaginal Health; Take one slow-release capsule twice a day, after meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of vaginal discharge	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	On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days)
change in odour of vaginal discharge.	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.	On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days)
Nugent score	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.	On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vaginal pH	Assessment of the effectiveness of test treatment in terms of change in vaginal pH	On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days),
Change in VAS score	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	On Day 01 (before application) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days).
Subject's perception	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.	On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (burning).	Assessment of safety of test treatment through treatment-emergent adverse events such as burning.	On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (stinging).	Assessment of safety of test treatment through treatment-emergent adverse events such as stinging using scoring scale 0= Indicate absent and 3= severe	On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (moisture).	Assessment of safety of test treatment through treatment-emergent adverse events such as moisture using scoring scale 0= Indicate absent and 3= severe	On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (flaking).	Assessment of safety of test treatment through treatment-emergent adverse events such as flaking using scoring scale 0= Indicate absent and 3= severe	On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (epithelial mucosa).	Assessment of safety of test treatment through treatment-emergent adverse events such as epithelial mucosa using scoring scale 0= Indicate absent and 3= severe	On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (redness).	Assessment of safety of test treatment through treatment-emergent adverse events such as redness using scoring scale 0= Indicate absent and 3= severe	On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (dryness).	Assessment of safety of test treatment through treatment-emergent adverse events such as dryness.	On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (odour).	Assessment of safety of test treatment through treatment-emergent adverse events such as odour using scoring scale 0= Indicate absent and 3= severe	On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (itching).	Assessment of safety of test treatment through treatment-emergent adverse events such as itching using scoring scale 0= Indicate absent and 3= severe	On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (soreness of vulva ).	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	On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Safety laboratory tests including Haemoglobin	Assessment of safety of test treatment through the performance of safety laboratory tests including Haemoglobin	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Haematocrit	Assessment of safety of test treatment through the performance of safety laboratory tests including Haematocrit	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including RBC count	Assessment of safety of test treatment through the performance of safety laboratory tests including RBC count	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including packed cell volume	Assessment of safety of test treatment through the performance of safety laboratory tests including packed cell volume	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including RBC morphology	Assessment of safety of test treatment through the performance of safety laboratory tests including RBC morphology	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including mean corpuscular volume	Assessment of safety of test treatment through the performance of safety laboratory tests including mean corpuscular volume	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including mean corpuscular hemoglobin	Assessment of safety of test treatment through the performance of safety laboratory tests including mean corpuscular hemoglobin	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including mean corpuscular haemoglobin concentration	Assessment of safety of test treatment through the performance of safety laboratory tests including mean corpuscular haemoglobin concentration	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Red blood cell distribution width	Assessment of safety of test treatment through the performance of safety laboratory tests including Red blood cell distribution width	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Neutrophils	Assessment of safety of test treatment through the performance of safety laboratory tests including Neutrophils	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including CBC (Lymphocytes)	Assessment of safety of test treatment through the performance of safety laboratory tests including Lymphocytes	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Eosinophils	Assessment of safety of test treatment through the performance of safety laboratory tests including Eosinophils	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Monocyte	Assessment of safety of test treatment through the performance of safety laboratory tests including Monocyte	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Basophils	Assessment of safety of test treatment through the performance of safety laboratory tests including Basophils	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Platelet count	Assessment of safety of test treatment through the performance of safety laboratory tests including Platelet count	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including mean platelet volume	Assessment of safety of test treatment through the performance of safety laboratory tests including mean platelet volume	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including plateletcrit	Assessment of safety of test treatment through the performance of safety laboratory tests including plateletcrit	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Platelet Distribution Width	Assessment of safety of test treatment through the performance of safety laboratory tests including Platelet Distribution Width	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including random blood sugar	Assessment of safety of test treatment through the performance of safety laboratory tests including random blood sugar	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Total serum cholesterol	Assessment of safety of test treatment through the performance of safety laboratory tests including Total serum cholesterol	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including CBC (triglyceride)	Assessment of safety of test treatment through the performance of safety laboratory tests including triglyceride	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including high-density lipoprotein	Assessment of safety of test treatment through the performance of safety laboratory tests including high-density lipoprotein	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including low-density lipoprotein	Assessment of safety of test treatment through the performance of safety laboratory tests including low-density lipoprotein	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including CBC (Serum Creatinine)	Assessment of safety of test treatment through the performance of safety laboratory tests including Serum Creatinine	On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Urinalysis	Assessment of safety of test treatment through the performance of safety laboratory tests including Urinalysis	On Day 01 before dosing, and on Day 30 (±2 days) post-dose

Collaborators and Investigators

• Sponsor: NovoBliss Research Pvt Ltd
• Collaborators: Meteoric Biopharmaceuticals Pvt. Ltd.
• Investigators: Principal Investigator: Dr. Nayan K Patel, NovoBliss Research Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Actual): January 7, 2025
• Study Completion (Actual): January 7, 2025

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Genital Diseases, Female; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginosis, Bacterial; Vaginal Diseases
• Other Study ID Numbers: NB240018-MB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No