鼠李糖乳杆菌 PL1 和植物乳杆菌 PM1 与安慰剂预防儿童复发性尿路感染的比较：一项随机对照试验的研究方案。
Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 versus placebo as a prophylaxis for recurrence urinary tract infections in children: a study protocol for a randomised controlled trial.
机构信息
Department of Paediatric Nephrology, Medical University of Warsaw, Żwirki i Wigury 63A, 02-091, Warsaw, Poland.
出版信息
BMC Urol. 2020 Oct 23;20(1):168. doi: 10.1186/s12894-020-00723-1.
BACKGROUND
Urinary tract infections (UTIs) are one of the most common bacterial infections in children. In children < 7 years of age, the prevalence of one episode of symptomatic UTI has been estimated at 3-7% in girls and 1-2% in boys, whereas 8-30% of them will have one or more episodes of UTI. The use of some probiotics appears to reduce the risk of recurrence of UTIs. Since the effects of probiotics are strain-specific, the efficacy and safety of each strain has to be assessed. The main aim of this study is to determine whether probiotics (containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1) therapy are effective in preventing UTI in children compared to placebo.
METHOD
A superiority, double-blind, randomised, controlled trial is being conducted. One hundred and six patients aged 3 to 18 years with recurrent UTIs in last year (defined as: ≥ 2 episodes of UTI with acute pyelonephritis/upper UTI; or 1 episode of UTI with acute pyelonephritis and ≥ 1 episodes of UTI with cystitis/lower UTI; or ≥ 3 episodes of UTI with cystitis/lower UTI) or children with ≥ 1 infection in the upper urinary tract and ≥ 1 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls) will be randomly assigned to receive a 90-day prophylaxis arm (probiotic containing L. rhamnosus PL1 and L. plantarum PM1) or a 90-day placebo arm. The primary outcome measure will be the frequency of recurrence of UTI during the intervention and in the period 9 months after the intervention.
DISCUSSION
The findings of this randomised controlled trial (RCT), whether positive or negative, will contribute to the formulation of further recommendations on prevention of recurrent UTIs in children.
TRIAL REGISTRATION NUMBER
NCT03462160, date of trial registration 12th March 2018.
背景
尿路感染（UTI）是儿童中最常见的细菌感染之一。在<7 岁的儿童中，女性单次症状性 UTI 的患病率估计为 3-7%，男性为 1-2%，而 8-30%的儿童会发生一次或多次 UTI。一些益生菌的使用似乎可以降低 UTI 复发的风险。由于益生菌的作用具有菌株特异性，因此必须评估每种菌株的疗效和安全性。本研究的主要目的是确定与安慰剂相比，益生菌（含有鼠李糖乳杆菌 PL1 和植物乳杆菌 PM1）治疗是否能有效预防儿童 UTI。
方法
正在进行一项优效性、双盲、随机、对照试验。106 名年龄在 3 至 18 岁之间的复发性 UTI 患儿（定义为：急性肾盂肾炎/上尿路感染≥2 次；或急性肾盂肾炎 1 次，膀胱炎/下尿路感染≥1 次；或膀胱炎/下尿路感染≥3 次）或上尿路感染≥1 次且有≥1 个复发性 UTI 危险因素（肾和尿路先天性异常、便秘、膀胱功能障碍、脊髓脊膜膨出、女性性行为）的患儿将被随机分配到 90 天预防组（含鼠李糖乳杆菌 PL1 和植物乳杆菌 PM1 的益生菌）或 90 天安慰剂组。主要结局指标为干预期间和干预后 9 个月 UTI 的复发频率。
讨论
本随机对照试验（RCT）的结果无论阳性还是阴性，都将有助于制定进一步的预防儿童复发性 UTI 的建议。
试验注册号
NCT03462160，试验注册日期为 2018 年 3 月 12 日。
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