Clinical trial NCT06486103: A Clinical Study to Determine the Safety and Efficacy of an Oral Probiotic Supplementation to Improve Bacterial Vaginosis in Females
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginosis
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: Meteoric Biopharmaceuticals Pvt. Ltd.
First posted: 2024-07-03
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An Open-Label, Single-Arm, Prospective Interventional Proof-of-Science Study.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in quality of vaginal discharge
timeFrame: On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days)
measure: change in odour of vaginal discharge.
timeFrame: On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days)
measure: Nugent score
timeFrame: On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).
Secondary outcomes:
measure: Change in vaginal pH
timeFrame: On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days),
measure: Change in VAS score
timeFrame: On Day 01 (before application) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days).
measure: Subject's perception
timeFrame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
measure: Treatment-emergent adverse events (burning).
timeFrame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
measure: Treatment-emergent adverse events (stinging).
timeFrame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
measure: Treatment-emergent adverse events (moisture).
timeFrame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
measure: Treatment-emergent adverse events (flaking).
timeFrame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
measure: Treatment-emergent adverse events (epithelial mucosa).
timeFrame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
measure: Treatment-emergent adverse events (redness).
timeFrame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
measure: Treatment-emergent adverse events (dryness).
timeFrame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
measure: Treatment-emergent adverse events (odour).
timeFrame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
measure: Treatment-emergent adverse events (itching).
timeFrame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
measure: Treatment-emergent adverse events (soreness of vulva ).
timeFrame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
measure: Safety laboratory tests including Haemoglobin
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including Haematocrit
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including RBC count
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including packed cell volume
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including RBC morphology
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including mean corpuscular volume
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including mean corpuscular hemoglobin
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including mean corpuscular haemoglobin concentration
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including Red blood cell distribution width
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including Neutrophils
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including CBC (Lymphocytes)
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including Eosinophils
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including Monocyte
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including Basophils
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including Platelet count
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including mean platelet volume
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including plateletcrit
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including Platelet Distribution Width
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including random blood sugar
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including Total serum cholesterol
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including CBC (triglyceride)
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including high-density lipoprotein
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including low-density lipoprotein
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including CBC (Serum Creatinine)
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
measure: Safety laboratory tests including Urinalysis
timeFrame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Other outcomes:
Locations:
city: Ahmadabad
country: India
facility: NovoBliss Research Pvt.Ltd
state: Gujarat
Study officials:
affiliation: NovoBliss Research Pvt Ltd
name: Dr. Nayan K Patel
role: PRINCIPAL_INVESTIGATOR
References: