Effectiveness of a multistrain probiotic formulation containing Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri and Fructooligosaccharides (Normoflora BV) in the treatment and recurrence prevention of bacterial vaginosis,A randomized open label trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study is a randomized open label clinical trial designed to evaluate the effectiveness and safety of a multi strain probiotic formulation Normoflora BV as an adjunct to standard antibiotic therapy in women with bacterial vaginosis. A total of sixty eligible participants aged eighteen to fifty years will be enrolled after ethical approval and CTRI registration and randomly allocated into two groups. The control group will receive standard treatment with oral metronidazole for seven days while the intervention group will receive metronidazole along with Normoflora BV probiotic for the same duration.
Participants will be followed over a period of three months with scheduled visits to assess clinical symptoms vaginal pH Nugent score treatment adherence safety and recurrence of infection. The primary objective is to compare treatment response and recurrence rates between the two groups. Secondary objectives include evaluation of vaginal microbiota restoration safety and tolerability of the probiotic formulation. The findings of this study are expected to provide evidence on the role of probiotic supplementation in improving treatment outcomes and preventing recurrence of bacterial vaginosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female participants aged 18–50 years,premenopausal, with regular menstrual cycles (eumenorrhoea: every 28 ± 10 days).
- •Confirmed diagnosis of bacterial vaginosis,defind by Nugent score at screening
- •Willing and able to provide written informed consent.
- •Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea)shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days)
- •No irregularities identified in gynaecological examination (no pathology of reproductive organs, such as myomas, ovarian cysts)as confirmed by a qualified gynecologist.
- •Susceptibility to recurrent vaginitis and/or urinary tract infections, as well as bacterial vaginitis confirmed at visit I.
- •Able to attend scheduled study visits and comply with all study procedures and protocol requirements.
排除标准
- •Recent treatments or exposures including systemic or intravaginal antibiotics, antifungals, or vaginal probiotics within the past 14–30 days
- •Current medical conditions such as co-infection with other vaginal pathogens (e.g., vulvovaginal candidiasis, trichomoniasis, STIs), neoplastic disease, or significant mental illness
- •Vulnerable populations including pregnant or breastfeeding women
- •Contraceptive or hormonal interventions including use of mechanical contraceptives (e.g., diaphragms, most IUDs except Mirena), NuvaRing, or vaginal hormonal preparations (e.g., Vagifem, Ovestin, estrogens).
研究者
Dr S Sarumathy
SRM Institute of Science and Technology (SRMIST)