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

NCT06486103 | Completed

• 1 other identifier: NB240018-MB
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (38)

• 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

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

• Subject's perception

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

• Treatment-emergent adverse events (burning).

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

• Treatment-emergent adverse events (stinging).

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

Study Arms (1)

Bacterial Vaginosis

EXPERIMENTAL

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

Other: MetSheFlora - Vaginal Health

Interventions

MetSheFlora - Vaginal Health OTHER

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

Bacterial Vaginosis

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Healthy female patients aged 18 to 55 years with mild to moderate bacterial vaginosis.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Meteoric Biopharmaceuticals Pvt. Ltd.: collaborator

Study Sites (1)

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, 382481, India

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Nayan K Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator- Medical Director

Model Details: An Open-Label, Single-Arm, Prospective Interventional Proof-of-Science Study.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: July 3, 2024
• Study Start: October 21, 2024
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)