Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-07
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:
NovoBliss Research Pvt Ltd
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
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?:
None
Is an FDA AA801 Violation?:
None