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

NCT ID: NCT06486103

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2025-01-07

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.

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.

Conditions

Bacterial Vaginosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bacterial Vaginosis

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

Group Type: EXPERIMENTAL

MetSheFlora - Vaginal Health

Intervention Type: OTHER

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

Interventions

MetSheFlora - Vaginal Health

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Meteoric Biopharmaceuticals Pvt. Ltd.

INDUSTRY

Sponsor Role: collaborator

NovoBliss Research Pvt Ltd

OTHER

Sponsor Role: lead

Responsible Party

Dr Nayan Patel

Principal Investigator- Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Nayan K Patel

Role: PRINCIPAL_INVESTIGATOR

NovoBliss Research Pvt Ltd

Locations

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, India

Countries

India

Other Identifiers

NB240018-MB

Identifier Type: -

Identifier Source: org_study_id