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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- 1.Evaluate the effect of the test treatment in term of change in the quality and odour of vaginal discharge.
研究概览
简要总结
The present open-label, single-arm, prospective interventional study was designed to evaluate the safety and therapeutic efficacy of an oral probiotic formulation (MetSheFloraProTM – Slow-Release Capsule) in women diagnosed with mild to moderate bacterial vaginosis (BV). In addition to addressing the clinical symptoms of BV, this study aims to explore the potential benefits of MetSheFloraPro™ in promoting overall vaginal health, thereby improving sexual health and well-being in women. By restoring a healthy balance of vaginal microbiota, the probiotic formulation help reduce discomfort, odor, and irritation commonly associated with BV, potentially enhancing sexual satisfaction and confidence. Furthermore, maintaining a balanced vaginal flora is essential for preventing recurrent infections and supporting optimal reproductive health. This could significantly improve the quality of life and sexual health outcomes for women dealing with BV. The study was prospectively registered with the Clinical Trials Registry of India (CTRI/2024/05/067530) and ClinicalTrials.gov (NCT06486103) and enrolled adult female subjects who satisfied the predefined inclusion and exclusion criteria.
Following a structured screening process, eligible subjects underwent baseline clinical and laboratory assessments and subsequently received the investigational product for a duration of 30 days. Subjects administered one probiotic capsule twice daily, and strict adherence to storage and handling requirements. Efficacy assessments included evaluation of vaginal discharge characteristics, odor, itching, Nugent scoring, and vaginal pH, complemented by treatment perception data captured using a structured questionnaire. Safety evaluations were conducted by gynecological examination, clinical symptom monitoring, and laboratory investigations.
Subjects exhibited relief from vaginal odor and itching, improvement in discharge quality, and stabilization of vaginal pH. Nugent scoring indicated a favorable shift toward restoration of a healthy vaginal microbiota. Subjects-reported outcomes revealed high levels of acceptability, reporting positive perceptions regarding capsule palatability, aftertaste, gastrointestinal tolerance, and overall confidence in its contribution to vaginal health. The investigational product was well tolerated, with no treatment-related adverse events or clinically significant alterations in laboratory safety parameters observed.
MetSheFloraProTM, a multi-strain probiotic formulation comprising Lactobacillus and Bifidobacterium species, demonstrated a favorable safety profile and clinically relevant efficacy in improving vaginal health among subjects with mild to moderate BV. The findings support its role as a safe and effective adjunctive strategy for restoring vaginal microbial balance and alleviating BV-associated symptoms.
Results
Percentage change in Quality of Vaginal Discharge
At baseline before usage of the test treatment, 75% subjects having white discharge, 25% subjects having clear and stretchy discharge. Post 15 days usage of the test treatment, 100% subjects having clear and stretchy discharge. Continues 30 days usage of the test treatment shows 16.67% subjects having white discharge while 83.33% subjects having clear and watery discharge.
Change in Nugent score
At baseline (Day 01), prior to the administration of the test treatment 100% exhibited a Nugent score ranging between 7 and 10, indicating the presence of bacterial vaginosis (BV). Following 30 days of test treatment administration, 58.33% subjects demonstrated a Nugent score of 0–3, indicative of a normal vaginal microbiota. Additionally, 33.33% subjects exhibited an intermediate bacterial count with a Nugent score of 4–6, while 1 subject 8.33% continued to have a Nugent score of 7–10, suggesting the persistence of BV.
These findings indicate a notable reduction in bacterial vaginosis, with a shift toward a healthier vaginal microbiota in the majority of participants, thereby supporting the potential efficacy of the test treatment in restoring vaginal microbial balance.
Change in Odour of Vaginal Discharge
At baseline before usage of the test treatment, 8.33% subject had moderate odour, while 66.67% and 25% subjects had intense and very intense odour. While post 15 days usage of the test treatment, 10 83.33% and 16.67% subjects had moderate and intense odour respectively. 30 days continuous usage of the test treatment demonstrated 83.33% subjects have mild odour and 16.67% subjects have moderate odour.
Change in vaginal pH
At baseline (Day 01), prior to the administration of the test treatment, 83.33% subjects exhibited a vaginal pH ranging between 1 and 6, indicating a very acidic to slightly acidic environment, while 16.67% subjects had a neutral vaginal pH. Following 15 days and 30 days of test treatment administration, 100% demonstrated a vaginal pH within the range of 1 to 6, signifying the maintenance or restoration of an optimal acidic vaginal environment. These findings suggest that the test treatment may contributed to sustaining vaginal acidity, which is essential for maintaining a balanced vaginal microbiota and inhibiting the overgrowth of pathogenic bacteria associated with bacterial vaginosis.
Change in VAS score for vaginal itching
At baseline, before usage of the test treatment all the 100% subjects having presence of vaginal itching, while post 30 days usage of the test product all 100% subjects having no itchiness observed.
Change in VAS score for odour of vaginal discharge
At baseline, before usage of the test treatment all the 100% subjects having presence of vaginal odour, while post 30 days usage of the test product all 100% subjects having no odour.
After 30 days of consuming the test treatment, consumer perception questionnaire assessments indicated the following results:
100% subjects liked the fragrance of the oral probiotic capsule MetSheFloraProTM.
100% subjects liked the taste of the oral probiotic capsules MetSheFloraProTM, found palatable.
100% subjects felt the pleasant after taste of the oral probiotic capsule MetSheFloraProTM**.**
100% subjects relieved from the gastrointestinal discomfort (abdominal pain, bloating, changes in bowel habits, nausea, vomiting, and indigestion) after taking oral probiotic capsule MetSheFloraProTM.
100% subjects liked the overall palatability of the oral probiotic capsule MetSheFloraProTM.
100% subjects were confident in terms of improving the vaginal health MetSheFloraProTM.
100% subjects perceived better overall health post dose of the oral probiotic capsule MetSheFloraProTM.
100% subjects agreed to recommend the oral probiotic capsules MetSheFloraProTM to family or friend for improving the vaginal health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.The subject is a healthy non-pregnant/non-lactating females aged 18-55 years.
- •2.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.
- •3.The subject is willing to provide written informed consent and follow study procedures.
- •4.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.
- •5.The subject is willing to use a highly effective method of contraception throughout the clinical investigation.
- •This includes: a.Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
- •b.Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration 6.Agreement for gynaecological pelvic examination by a Gynaecologist.
- •7.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.
排除标准
- •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.
结局指标
主要结局
1.Evaluate the effect of the test treatment in term of change in the quality and odour of vaginal discharge.
时间窗: 1.Day 01 (before administration) for baseline, and post-dose on Day 15 and Day 30. | 2. on Day 01 (before administration) for baseline, and post-dose on Day 30.
2.Evaluate the effect of the test treatment in terms of changes in Nugent score.
时间窗: 1.Day 01 (before administration) for baseline, and post-dose on Day 15 and Day 30. | 2. on Day 01 (before administration) for baseline, and post-dose on Day 30.
次要结局
- Evaluate the effect of the test treatment in terms of change in vaginal pH.(On Day 01 (before administration) for baseline, and post-dose on Day 15 and Day 30 evaluated by the Gynaecologist using pH paper.)
- Evaluate the effect of test treatment in terms change in VAS scoring for vaginal itching, and odour of vaginal discharge.(On Day 01 (before application) for baseline, and post-dose on Day 15 and Day 30.)
- Evaluate the subject perception regarding the test treatment using a hedonic scale questionnaire for parameters such as smell, taste, overall palatability, perceived effectiveness of the test treatment.(On Day 15 and Day 30 post dose.)
- Evaluate the safety of the test treatment by assessing various vulvar symptoms, including burning, stinging, moisture, flaking, epithelial mucosa, redness, dryness, odour, itching, and soreness, through clinical gynaecological examination.(On Day 15 and Day 30 post dose.)
- Evaluate the safety of test treatment through the performance of safety laboratory tests including Complete Blood Count (CBC), Biochemical tests, and Urinalysis.(Day 01 before dosing and Day 30 post-dose.)
研究者
Dr Nayan Patel, MBBS
NovoBliss Research Private Limited