H-23187: Probiotic Prophylaxis Against Recurrent Pediatric Urinary Tract Infection
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms.
研究概览
简要总结
Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in hundreds of studies using adults over the last 30 years. Very few studies have been conducted with children. UTI in girls occur when virulent bacteria migrate from the rectum and colonize the vagina and peri-urethral mucosa, thus gaining access to the bladder.
This study will randomize girls to ARM A (probiotics + placebo) and ARM B (antibiotics + placebo) to determine if UTIs are decreased when the probiotics are given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Girls age 1 through age 17 years of age
- •Must have had at least 3 symptomatic UTI, uncomplicated or complicated, in the year preceding study inclusion or already using any form of prophylaxis to prevent recurrences of UTI
- •Must have had at least 3 symptomatic urinary tract infections in the year before the start of the prophylaxis.
排除标准
- •Breastfeeding
- •Pregnancy
- •Prior adverse reaction to sulfa drugs or sulfamethoxazole/trimethoprim
- •Known immunosuppression i.e., transplant recipients or children with congenital immunodeficiencies
- •Poorly controlled diabetes
- •Untreated HIV infection
- •Use of high dose corticosteroids for autoimmune diseases or post-organ transplantation. Inhaled corticosteroids or oral steroids for asthma are allowed.
- •Malnutrition
- •Patients with a history of sulfamethoxazole/trimethoprim-resistant UTI will be excluded from the study
- •Patients with renal insufficiency, liver insufficiency, or cardiopulmonary disease requiring medication will be excluded from the study
- •Patients with known anemia will be excluded from the study
- •Patients taking medications that may interact with sulfamethoxazole/trimethoprim will be excluded from the study
- •Patients taking other probiotics will be excluded from the study
- •Patients already taking prophylactic antibiotics will be excluded from the study
研究组 & 干预措施
ARM A
Probiotics drops plus placebo elixir
干预措施: Lactobacillus reuteri DSM 17938 (Dietary Supplement)
ARM B
TMP/SMZ elixir plus placebo drops
干预措施: trimethoprim/sulfamethoxazole (Drug)
结局指标
主要结局
The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms.
时间窗: 1 year
次要结局
未报告次要终点
研究者
David Roth
Professor, TCH Urology
Baylor College of Medicine