Studying the role of probiotic in the treatment of recurrent uncomplicated urinary tract infections in women
试验速览
- 阶段
- Phase 3 4
- 状态
- Not Applicable
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1. The number of patients is cured of UTI due to administration of probiotics/antibiotics. It will be based on absence or decreased severity of clinical signs-symptoms after completion of course of probiotics and antibiotics.
研究概览
简要总结
Urinary Tract Infections (UTIs) currently rank amongst the most prevalent infections representing a major health hazard. Urogenital infections are one of most common causes for a woman to visit a gynecologist or a urologist. UTIs in female usually start as vaginal infections and ascend to the urethra and bladder. Various antibiotics have been the mainstay of therapy in ameliorating the incidence of UTIs, but recurrent infections continue to afflict many women. In recent years due to irrational use of antibiotics for the treatment of bacterial infections like UTIs, antibiotic resistance has been reached at an alarming level. Use of broad-spectrum antibiotics not only kills the pathogenic bacteria but also beneficial bacteria hosted by the human body. It necessitates the exploitation of alternative to antimicrobial therapy. Probiotics may be one of highly effective alternative treatment option. Healthy vaginal microbiota is mainly dominated by Lactobacillus species but in UTIs its level in vaginal flora decreases. Escherichia coli is the main pathogen that causes UTIs. Restoration of normal urogenital flora by exogenously administered probiotics containing Lactobacilli play a pivotal role in reducing the risk and treatment of uncomplicated, complicated, recurrent UTIs or patients on prolonged antibiotic use. Probiotics do not cause antibiotic resistance and may offer other health benefits due to vaginal re-colonization with Lactobacilli. This study will be conducted to assess the clinical efficacy of probiotic therapy and compare the effect of probiotic and antibiotic therapy on urogenital microbiota. In this study total 90 women suffering from only recurrent uncomplicated UTIs will be enrolled and divided into three groups. Preliminary, conventionally microbiological culture method will be used for the detection of vaginal flora. The study will use urine only. Personal information will be kept confidential.
Verbal or properly signed written consent will be obtained before collecting any specimen and demographic data. Hopefully the result of this study will help to reduce the inappropriate use of antibiotics and also reduce potentially "illness promoting" dysbiosis in women suffering from UTIs. It will also open a new alternative treatment therapy. In our understanding, there is no research data available to date in Bangladesh. Our study will contribute in developing baseline data in Bangladesh to study further in this critical area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- Female
入选标准
- •Sex: female ii.Female suffering from only recurrent uncomplicated UTI iii.
- •Patients have not received any antimicrobial and/or probiotic therapy within one month prior to enrollment in the study.
- •Non-pregnant women.
排除标准
- •Sex: Male ii.
- •Status: Pregnant women ii.
- •Patients received any antimicrobial and/or probiotic therapy within one month prior to enrollment in the study.
- •Patients having relevant interactions of prescribed antimicrobial agent or probiotics with concurrent medication or contraindications.
结局指标
主要结局
1. The number of patients is cured of UTI due to administration of probiotics/antibiotics. It will be based on absence or decreased severity of clinical signs-symptoms after completion of course of probiotics and antibiotics.
时间窗: At Baseline, 2 weeks and 4 weeks
2.Identification of the organisms responsible for UTI and evaluation of the development of antibiotic resistance by expressing in percentage of antibiotic resistant E. Coli isolate from urine of symptomatic women.
时间窗: At Baseline, 2 weeks and 4 weeks
次要结局
- 1. The micro biologically confirmed recovery of patients suffering from UTI.(2. Proportion of patients’ experienced adverse events.)
