A Randomized, Double-Blind, Single-Centre, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Probiotic (Lactic Acid Bacteria) in Women with Bacterial Vaginosis.

AceOne Rs1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2026年4月27日最近更新: 2026年3月23日

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 120
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of oral Lactobacillus helveticus probiotics in women with bacterial vaginosis (BV). BV is a common vaginal infection caused by a reduction in beneficial Lactobacillus species and overgrowth of pathogenic bacteria, leading to symptoms such as abnormal discharge, odor, irritation, and discomfort. Standard antibiotic treatments are effective short-term but have high recurrence rates, partly due to incomplete restoration of protective vaginal bacteria. Probiotics aim to restore healthy Lactobacillus levels, lower vaginal pH, inhibit pathogens, and improve symptoms. This study will assess changes in Nugent score, vaginal pH, microbiota composition, and patient-reported symptoms to determine the safety and potential benefits of Lactobacillus helveticus supplementation.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 19.00 Year(s) 至 50.00 Year(s)（—）
性别: Female

入选标准

•Female participants aged 19 to 50 years
•Clinical diagnosis of bacterial vaginosis confirmed by Nugent scoring with a score of 4 to 6, preferably 5 to 6, at screening
•Experiencing symptoms of vaginal dysbiosis such as abnormal discharge odor pain burning sensation irritation or dysuria
•Ability and willingness to provide written informed consent prior to any study specific procedures
•Willingness and ability to comply with study procedures including scheduled visits sample collection and study product administration
•Willingness to avoid non-study products or medications targeting vaginal or urinary tract health throughout the study period.

排除标准

•Participation in another clinical trial within the preceding 3 months
•History of recurrent urinary tract infections defined as two or more infections within six months or three or more infections within 12 months
•Regular use of antibiotics antibacterial agents steroids or immunosuppressants
•Use of products or medications targeting vaginal or urinary tract health within the 12 weeks prior to screening
•Pregnancy lactation or intention to conceive during the study period
•Known hypersensitivity or allergy to any component of the study product
•Current or recent history of significant systemic illnesses including but not limited to cardiovascular immune respiratory gastrointestinal liver biliary renal urinary nervous system musculoskeletal psychiatric disorders malignancies or active vaginal or urinary tract infections bleeding or abnormalities unrelated to bacterial vaginosis
•Diagnosed vaginal or pelvic conditions
•Use of vaginal-related birth control devices including intrauterine devices or vaginal rings
•Uncontrolled hypertension defined as systolic greater than or equal to 160 mmHg or diastolic greater than or equal to 100 mmHg
•Uncontrolled diabetes defined as HbA1c greater than 6 point 5 percent
•Laboratory abnormalities outside normal reference ranges considered clinically significant by the Principal Investigator including creatinine liver function tests AST ALT and thyroid stimulating hormone
•Participation in or receipt of acupuncture or other vaginal treatments for vaginal health within one week of screening
•Current or recent history of smoking or substance abuse within six months
•Participants who in the opinion of the Principal Investigator are unsuitable for participation due to medical safety or compliance considerations that may interfere with study assessments or endpoints.

研究者

发起方

AceOne Rs

申办方类型

Pharmaceutical industry-Global

责任方

Principal Investigator

主要研究者

Dr Anusha Srinivasan

Currex Hospital

研究点 (1)

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