A Clinical Study to Determine the Safety and Efficacy of an Oral Probiotic Supplementation to Improve Bacterial Vaginosis in Females
NCT Number: NCT06486103
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bacterial Vaginosis
Interventions: OTHER: MetSheFlora - Vaginal Health
Sponsor: NovoBliss Research Pvt Ltd
Collaborators: Meteoric Biopharmaceuticals Pvt. Ltd.
Sex: FEMALE
Age: ADULT
Enrollment: 14
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2024-08-30

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.

Primary Outcome Measures: 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 Outcome Measures: Change in vaginal pH, Assessment of the effectiveness of test treatment in terms of 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, Assessment of the effectiveness of test treatment in terms of change in VAS score for vaginal itching where 0= indicates no itch and 10 indicates severe itch, On Day 01 (before application) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days).|Subject's perception, Assessment of the subject's perception regarding the test treatment using a hedonic scale questionnaire for parameters such as smell, taste, overall palatability, perceived effectiveness., On Day 15 (±2 days) and Day 30 (±2 days) post-dose.|Treatment-emergent adverse events (burning)., Assessment of safety of test treatment through treatment-emergent adverse events such as burning., On Day 15 (±2 days) and Day 30 (±2 days) post-dose.|Treatment-emergent adverse events (stinging)., Assessment of safety of test treatment through treatment-emergent adverse events such as stinging using scoring scale 0= Indicate absent and 3= severe, On Day 15 (±2 days) and Day 30 (±2 days) post-dose.|Treatment-emergent adverse events (moisture)., Assessment of safety of test treatment through treatment-emergent adverse events such as moisture using scoring scale 0= Indicate absent and 3= severe, On Day 15 (±2 days) and Day 30 (±2 days) post-dose.|Treatment-emergent adverse events (flaking)., Assessment of safety of test treatment through treatment-emergent adverse events such as flaking using scoring scale 0= Indicate absent and 3= severe, On Day 15 (±2 days) and Day 30 (±2 days) post-dose.|Treatment-emergent adverse events (epithelial mucosa)., Assessment of safety of test treatment through treatment-emergent adverse events such as epithelial mucosa using scoring scale 0= Indicate absent and 3= severe, On Day 15 (±2 days) and Day 30 (±2 days) post-dose.|Treatment-emergent adverse events (redness)., Assessment of safety of test treatment through treatment-emergent adverse events such as redness using scoring scale 0= Indicate absent and 3= severe, On Day 15 (±2 days) and Day 30 (±2 days) post-dose.|Treatment-emergent adverse events (dryness)., Assessment of safety of test treatment through treatment-emergent adverse events such as dryness., On Day 15 (±2 days) and Day 30 (±2 days) post-dose.|Treatment-emergent adverse events (odour)., Assessment of safety of test treatment through treatment-emergent adverse events such as odour using scoring scale 0= Indicate absent and 3= severe, On Day 15 (±2 days) and Day 30 (±2 days) post-dose.|Treatment-emergent adverse events (itching)., Assessment of safety of test treatment through treatment-emergent adverse events such as itching using scoring scale 0= Indicate absent and 3= severe, On Day 15 (±2 days) and Day 30 (±2 days) post-dose.|Treatment-emergent adverse events (soreness of vulva )., Assessment of safety of test treatment through treatment-emergent adverse events such as soreness of vulva using scoring scale 0= Indicate absent and 3= severe, On Day 15 (±2 days) and Day 30 (±2 days) post-dose.|Safety laboratory tests including Haemoglobin, Assessment of safety of test treatment through the performance of safety laboratory tests including Haemoglobin, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including Haematocrit, Assessment of safety of test treatment through the performance of safety laboratory tests including Haematocrit, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including RBC count, Assessment of safety of test treatment through the performance of safety laboratory tests including RBC count, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including packed cell volume, Assessment of safety of test treatment through the performance of safety laboratory tests including packed cell volume, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including RBC morphology, Assessment of safety of test treatment through the performance of safety laboratory tests including RBC morphology, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including mean corpuscular volume, Assessment of safety of test treatment through the performance of safety laboratory tests including mean corpuscular volume, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including mean corpuscular hemoglobin, Assessment of safety of test treatment through the performance of safety laboratory tests including mean corpuscular hemoglobin, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including mean corpuscular haemoglobin concentration, Assessment of safety of test treatment through the performance of safety laboratory tests including mean corpuscular haemoglobin concentration, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including Red blood cell distribution width, Assessment of safety of test treatment through the performance of safety laboratory tests including Red blood cell distribution width, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including Neutrophils, Assessment of safety of test treatment through the performance of safety laboratory tests including Neutrophils, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including CBC (Lymphocytes), Assessment of safety of test treatment through the performance of safety laboratory tests including Lymphocytes, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including Eosinophils, Assessment of safety of test treatment through the performance of safety laboratory tests including Eosinophils, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including Monocyte, Assessment of safety of test treatment through the performance of safety laboratory tests including Monocyte, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including Basophils, Assessment of safety of test treatment through the performance of safety laboratory tests including Basophils, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including Platelet count, Assessment of safety of test treatment through the performance of safety laboratory tests including Platelet count, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including mean platelet volume, Assessment of safety of test treatment through the performance of safety laboratory tests including mean platelet volume, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including plateletcrit, Assessment of safety of test treatment through the performance of safety laboratory tests including plateletcrit, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including Platelet Distribution Width, Assessment of safety of test treatment through the performance of safety laboratory tests including Platelet Distribution Width, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including random blood sugar, Assessment of safety of test treatment through the performance of safety laboratory tests including random blood sugar, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including Total serum cholesterol, Assessment of safety of test treatment through the performance of safety laboratory tests including Total serum cholesterol, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including CBC (triglyceride), Assessment of safety of test treatment through the performance of safety laboratory tests including triglyceride, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including high-density lipoprotein, Assessment of safety of test treatment through the performance of safety laboratory tests including high-density lipoprotein, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including low-density lipoprotein, Assessment of safety of test treatment through the performance of safety laboratory tests including low-density lipoprotein, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including CBC (Serum Creatinine), Assessment of safety of test treatment through the performance of safety laboratory tests including Serum Creatinine, On Day 01 before dosing, and on Day 30 (±2 days) post-dose|Safety laboratory tests including Urinalysis, Assessment of safety of test treatment through the performance of safety laboratory tests including Urinalysis, On Day 01 before dosing, and on Day 30 (±2 days) post-dose