ACTRN12610000512022已完成不适用
A multicentre randomised, placebo-controlled study to assess the efficacy, safety and cost utility of probiotic prophylaxis on urinary tract infection in people with spinal cord injury, stable multiple sclerosis or cerebral vascular disease. (ProSCIUTTU)
Dr Bon San Bonne Lee0 个研究点目标入组 207 人开始时间: 2010年6月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 100 Years（—）
- 性别
- All
入选标准
- •Subjects may be included if they:
- •1.have a spinal cord injury defined as stable, non progressive Spinal Cord Injury with a neuropathic bladder”;
- •2.have stable multiple sclerosis or cerebral vascular disease with documented neurogenic bladder on video urodynamic assessment;
- •3.have stable bladder management technique (i.e. not receiving bladder management education for at least 4 weeks) and using a bladder management technique such as indwelling catheter, suprapubic catheter, clean intermittent self-catheterisation or condom drainage;
- •4.have given written informed consent, and agreed to fortnightly telephone follow-up for themselves and their care team for the study period;
- •5.have agreed not to take any other probiotic in addition to the allocated intervention. This includes all yogurt oral or topical preparations.
排除标准
- •Subjects will be excluded if they are:
- •1.receiving bladder management education;
- •2.being treated for, or symptomatic of a current infection or long-standing pressure sore;
- •3.known to have a complex bladder disturbance requiring surgical intervention e.g. known cystoplasty, renal or bladder calculus, significant hydronephrosis, or pyelonephritis;
- •4.known to have chronic open wound/s or known long-standing osteomyelitis (greater than 6 weeks);
- •5.on long-term antibiotic therapy for any indication;
- •6.on steroids or interferon B therapy;
- •7.known to have a history of adverse drug reaction to yoghurt or milk products or a demonstrated intolerance to the probiotics used. Lactose intolerance is NOT an exclusion criterion;
- •8.known to have severe renal or hepatic failure; full (invasive) mechanical ventilation
- •9.receiving immunosuppressant medications or have an underlying immunosuppressive disease (for example Human Immuno-deficiency Virus (HIV) or end-stage/ progressive diabetes mellitus, multiple sclerosis or cerebrovascular disease).
- •10.planning to have oral surgery during the intervention period,
- •11.known to be colonised and have laboratory evidence with either a positive culture on rectal, nares, urine and groin swabs of one or more of the following organisms: multi-resistant Staphylococcus aureus (MRSA), vancomycin resistant enterococci (VRE), extended spectrum beta lactamase producing (ESBL) gram negative organisms and carbapenem resistant Acinetobacter spp AND have laboratory evidence of an infection.
- •12.concurrently enrolled in another intervention study; (observational studies or inclusion following completion of another study is allowed).
研究者
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