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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	MetSheFlora - Vaginal Health	Take one slow-release capsule twice a day, after meal.

Timeline

• Start date: 2024-10-21
• Primary completion: 2025-01-07
• Completion: 2025-01-07
• First posted: 2024-07-03
• Last updated: 2025-03-03

Locations

1 site across 1 country: India