Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- NINDS Medical History CDE
研究概览
简要总结
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).
详细描述
Urinary tract infection (UTI) is the most common outpatient infection world-wide, and for people with spinal cord injury (SCI) and neurogenic bladder (NB), it is the most common infection, secondary condition, cause for emergency room visits, and infectious cause of hospitalization. Despite its prevalence, attempts to ameliorate UTI among people with SCI are stymied by long-standing diagnostic challenges which arise from evidence gaps around "gold standard" diagnostic tests (urinalysis and urine culture) that have lower sensitivity and specificity for UTI in this population. A high prevalence of chronic inflammation leading to persistence of white blood cells (WBC) in the urine confounds the utility of WBC count, pyuria, and leukocyte esterase as biomarkers for UTI; nitrites in urine indicate the presence of only specific (but not all) organisms, many of which are present to a greater extent in the urine of people with SCI; and people with SCI have a high prevalence of asymptomatic bacteriuria. These physiologic changes render the gold standard diagnostic tests less useful for identifying UTI in persons with SCI.
SPECIFIC AIM 1 Compare the effects of Lactobacillus Rhamnosus GG (LGG®) + Saline bladder wash (BW) versus BW alone on USQNB-determined bladder (B1) and urine quality (B2) symptom burden (two co-primary outcomes) where participants self-manage in response to two trigger symptoms (cloudier and/or more foul-smelling urine).
SPECIFIC AIM 2 Compare the effects of LGG®+BW versus BW alone (in response to the two trigger symptoms) on key secondary outcomes: number of days lost from rehabilitation, work, and/or school; number of days symptomatic; number of interactions with the health care system due to urinary symptoms; exposure to antibiotics (days, volume).
SPECIFIC AIM 3 Compare the prophylactic effects of LGG®+BW versus BW alone on USQNB-determined bladder (B1) and urine quality (B2) symptom burden.
SPECIFIC AIM 4 Compare the prophylactic effects of LGG®+BW versus BW alone on key secondary outcomes: number of days lost from rehabilitation, work, and/or school; number of days symptomatic; number of interactions with the health care system due to urinary symptoms; exposure to antibiotics (days, volume).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •SCI at least 6 months duration;
- •NLUTD (as determined by their SCI physician or urologist);
- •Utilizing intermittent catheterization for bladder management; and
- •Community dwelling (discharged from the acute care setting).
排除标准
- •Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.);
- •Use of prophylactic antibiotics;
- •Instillation of intravesical agents (e.g., gentamycin, saline; or Lactobacillus);
- •Immunodeficiency;
- •Any oral antibiotics within the past 2 weeks;
- •Psychologic or psychiatric conditions influencing the ability to follow instructions;
- •Participation in another study in which results would be confounded;
- •6 months since prior exposure to intravesical LGG®; and
- •Active cancer (or within 5 years) or active autoimmune disorder
研究组 & 干预措施
Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment Phase)
LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation in response to trigger symptoms, participants will be instructed to mix the contents of 1 LGG® capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG® mixture into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and daily during instillations for 2 days after the final instillation. Subjects will remain in this phase 6 months.
干预措施: Lactobacillus RhamnosusGG (Drug)
Intravesical Bladder Wash (Treatment Phase)
Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and daily during instillations for 2 days after the final instillation. Subjects will remain in this phase 6 months.
干预措施: Saline bladder wash (Drug)
Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Prophylaxis Phase)
LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation in response to trigger symptoms, participants will be instructed to mix the contents of 1 LGG® capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG® mixture into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. They will then instill the LGG® mixture every 2 days for the remainder of the 6 months. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and biweekly post-instillation. Subjects will remain in this phase 6 months.
干预措施: Lactobacillus RhamnosusGG (Drug)
Intravesical Bladder Wash (Prophylaxis Phase)
Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. They will then instill the saline BW every 2 days for the remainder of the 6 months. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and biweekly post-instillation. Subjects will remain in this phase 6 months.
干预措施: Saline bladder wash (Drug)
结局指标
主要结局
NINDS Medical History CDE
时间窗: Day 1
A brief medical history using body system categories. Score is not associated with outcomes.
Patient Satisfaction Survey
时间窗: At final USQNB-IC completion (between 13 to 18 months) or at participant drop-out
We developed a simple three-item patient satisfaction "survey" that will be requested from only those individuals who used the intervention (LGG® +BW or BW only) at the time of final USQNB-IC completion, or at the drop out visit (for those who did use the intervention at least once). Participants will be asked to estimate, using a scale from 0% \<totally dissatisfied/would absolutely never do this\>, through 50% \<neither satisfied nor dissatisfied/might do this\> to 100% \<completely satisfied/would absolutely always do this\>: 1. How satisfied with the intervention you used are you? 2. Would you seek this intervention out and pay for it if insurance did not pay for it? 3. Would you use or recommend the intervention in response to symptoms, prophylactically, or both? :At the drop out visit, we will ask these three questions and one additional item for those who used the intervention at least once, "Are you dropping out because the intervention was not working for you?"
International SCI Lower Urinary Tract Function Basic Data Set
时间窗: Day 1
A tool that describes urinary tract impairment, awareness of need to empty bladder, main bladder emptying method, medications used for bladder management, surgeries, and change in urinary symptoms in the past year. Score is not associated with outcome.
NINDS Prior and Concomitant Medications CDE
时间窗: Day 1
Contains whether or not the participant is taking a medication during the study protocol, name of the medication, reason for medication, medication dose, frequency, start and end dates, and free text. Score is not associated with outcomes.
International SCI Core Data Set
时间窗: Day 1
Includes date of injury, dates of initial hospitalization admission and discharge, neurological data. Score is not associated with outcome.
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
时间窗: (SA3) Twice weekly post-instillation for up to 6 months (Phase 3: prophylaxis phase)
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
次要结局
未报告次要终点