Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-04 @ 2:35 PM
Study NCT ID:
NCT06486103
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2024-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Determine the Safety and Efficacy of an Oral Probiotic Supplementation to Improve Bacterial Vaginosis in Females
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
Study Overview
Official 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.
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: