Effectiveness of probiotics in lower reproductive tract infection in women of age group 18 to 45 years.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Assess the effectiveness of the probiotic strains having Lactobacillus rhamnosus GR -1 and Lactobacillus reuteri RC-14 in the management of lower genital infections(bacterial vaginosis as an integral therapy with antibiotics.
研究概览
简要总结
In the SAT gynaecology OPD, 40 to 50% women present with vaginal discharge .24.7% of them have a flora suggestive of bacterial vaginosis.Incidence of HIV and STD are on an increase.
Bacterial Vaginosis has been found to be associated with preterm labour, PROM, postpartum endometritis, puerperal and post abortion sepsis which can be prevented by early treatment. it is also associated with post operative infectios ad vaginal cuff cellulitis.
To avoid the rising rates of antibiotic resistance, following use in lower reproductive tract infection the role of probiotics has been considered as a means of protection against lower reproductive tract infection.
Studies have proven the efficacy of probiotics in lower reproductive tract infectio in women.
Hence the significance of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women between 18 and 45 years attending gynaecology OPD with complaint vaginal discharge and/or vaginal itching who gives informed consent.
排除标准
- •Women of below 18 years and above 45 years age group.
- •Women with history of diabetes mellitus.
- •Women with malignancy or those on cancer chemotherapy.
- •Women with chroic liver disease,chroic renal disease.
- •Women with HIV infection and those on immunosuppressive therapy.
结局指标
主要结局
Assess the effectiveness of the probiotic strains having Lactobacillus rhamnosus GR -1 and Lactobacillus reuteri RC-14 in the management of lower genital infections(bacterial vaginosis as an integral therapy with antibiotics.
时间窗: one year
次要结局
- Assess the effectiveness of probiotics in maintaining a healthy genital flora throughout the treatment period(one year)