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

NovoBliss Research Pvt Ltd14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bacterial Vaginosis

Interventions

MetSheFlora - Vaginal HealthOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, India

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).

Secondary Outcomes

Change in vaginal pH

Assessment of the effectiveness of test treatment in terms of change in vaginal pH

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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