Randomised, Double-Blind, Placebo- Controlled Trial Evaluating Safety and Efficacy of add-on Probiotic in Prevention of Recurrent Urinary Tract Infection in Adult Women
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- I. PRIMARY OBJECTIVE
研究概览
简要总结
Background
Lower urinary tract infections (UTIs) affect up to 50% of adult women1,2. An uncomplicated urinary tract infection (UTI) is one that occurs in a healthy host in the absence of structural or functional abnormalities of the urinary tract. Recurrent urinary tract infection (rUTI) refers to ≥2 infections in six months or ≥3 infections in one year.3
Recurrent UTIs (rUTIs) occur due to bacterial reinfection or bacterial persistence. Persistence involves the same bacteria not being eradicated in the urine 2 weeks after sensitivity-adjusted treatment. A reinfection is a recurrence with a different organism, the same organism in more than 2 weeks, or a sterile intervening culture.
Clinical diagnosis of each UTI episode is supported by symptoms of dysuria, frequency, urgency, hematuria, back pain, self-diagnosis of UTI, nocturia, costovertebral tenderness and the absence of vaginal discharge or irritation. Commonly, the clinical diagnosis of UTI is aided by laboratory investigations, which include, urine routine microscopic examinations and culture and sensitivity test. Recently, few serum and urine biomarkers have been identified in rUTI with good correlation to treatment. The biomarkers identified in the serum include, granulocyte colony stimulating factor (GCSF), Macrophage colony stimulating factor (MCSF), interleukin-5 (IL-5) and urinary nerve growth factor (NGF)4. Albeit long term prophylaxis with antibiotics forms the mainstay in reducing the frequency of rUTIs in women, increased health costs, adverse effects, drug resistance and alteration of the normal flora in the intestines are few of the issues encountered with it. At present, there is no well-established recommendation for a ‘standard’ prophylactic antibiotic management to prevent the occurrence of rUTIs5Â.
Probiotics are defined as “a preparation of, or a product containing viable, defined micro-organisms in sufficient numbers, which alter the microflora (by implantation or colonisation) in a compartment of the host and by that exert beneficial health effects in this hostâ€6. There are a number of species and strains of probiotics available that are used in many formulations administered via several different routes. Probiotic organisms (e.g. lactobacillus) are thought to establish a barrier against infectious pathogens ascending the urinary tract, colonising, and subsequently causing infection7.
Although many clinical trials have been carried out to assess the individual effect of probiotics in patients of rUTIs with varied effects, there is a paucity of data on the combined effect of probiotics along with antibiotics on prevention of UTI especially in Indian scenario. We therefore plan to carry out a clinical trial assessing the effect of add-on probiotics in adult women with rUTI.
Study Hypothesis
Thehypothesis of the proposed study is that the group taking add-on probiotic willhave a lower recurrence rate than those taking placebo based on the literature.The investigators aim to identify to what degree that difference is and whetheror not it is an acceptable difference given the greater degree of an antibioticresistance.
The aim of the proposed study is toassess the efficacy and safety of the add-on probiotic in preventing recurrent urinary tract infection in adultwomen.
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 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •i.Women of 18-50 years of age who have not attained menopause ii.Women with an active episode of recurrent UTI iii.Recurrent UTI defined as: a)More than 2 symptomatic, culture-proven UTI over past 6 months OR b)More than 3 symptomatic, culture-proven UTI over past 12 months iv.Willing to give informed consent for the study.
排除标准
- •i.Polycystic disease, interstitial cystitis, previous urological surgery, stones, or anatomical abnormalities of the urinary tract ii.Pregnant or breastfeeding or planning a pregnancy in the next 6 months iii.Known allergy or intolerance to any of the study products iv.A history of renal stones and/or renal transplantation v.Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes vi.Current use of corticosteroid, anticoagulant, antidepressants or mood stabilizing medications or other medications that may interact with the supplement vii.Intermittent or indwelling catheterization.
结局指标
主要结局
I. PRIMARY OBJECTIVE
时间窗: 0 week Screening eligibility and enrollment followed by evaluations at | 4. | 8 | 12 | 16, | 20 and 24 weeks (Last visit)
Mean number of confirmed UTIs (either clinical or bacteriological or both) during 24 weeks from start of intervention, as compared to placebo.
时间窗: 0 week Screening eligibility and enrollment followed by evaluations at | 4. | 8 | 12 | 16, | 20 and 24 weeks (Last visit)
次要结局
- i. To determine time from randomization to first clinical UTI.(ii.To report and compare any adverse drug reactions observed in the probiotic versus placebo groups.)