NCT06149676已完成1 期
A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Reduction in UTI episodes
研究概览
简要总结
Patients with recurrent UTI were randomized to receive either the probiotic Sacchromyces Boulardii at enrollment, and the intracellularly active Ciprofloxacin with their first UTI episode after enrollment, or they received standard of care treatment.
详细描述
- At the time of consent, participants will be given 20 mg/kg of the antibiotic, ciprofloxacin. If the participant has symptoms of a UTI or have a positive urine culture at enrollment, they will take the antibiotic every 12 hours for 14 days. If the participant does not have symptoms of a UTI at enrollment, the antibiotic will be taken only if needed at home upon the first occurrence of a UTI.
- At the time of consent, participants will also be given 250 mg of the probiotic, S.
boulardii, taken once daily for 6 months, irrespective of symptoms.
- Throughout the study, participants will receive their standard clinical care for recurrent UTI treatment, which includes bowel and bladder dysfunction management and other prescribed non-antibiotic interventions at the managing provider's clinical discretion.
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A history of 3 or more UTI episodes in the past 12 months, or 2 or more episodes in the past 6 months
- •no evidence of vesicoureteral reflux or only low-grade (grade 1-2) vesicoureteral reflux
- •no other genitourinary anatomical abnormality
- •not receiving prophylactic antibiotics at the time of enrollment
- •Ages 2-17 years.
排除标准
- •high grade (grade 3-5) vesicoureteral reflux
- •neurogenic bladder
- •anatomical abnormalities of the gastrointestinal tract
- •any history of urologic or gastrointestinal surgery
- •on prophylactic antibiotics
- •a urine culture positive for pathogens that are not susceptible to ciprofloxacin in the last 3 months
- •history of an allergic reaction to ciprofloxacin or other quinolones, or a history of severe adverse reactions
- •As stated on the package insert for Ciprofloxacin, individuals with a known history of myasthenia gravis should avoid taking Ciprofloxacin and therefore will be excluded from this study.
- •Based on the black box warning for Ciprofloxacin, individuals taking tizanidine as concomitant administration, or those taking other drugs known to interact with ciprofloxacin will be excluded from the study.
- •individuals with known QT prolongation, hypokalemia, or on other drugs that prolong the QT interval should also avoid taking Ciprofloxacin and will be excluded from this study.
- •Individuals under 2 years old. In the BFIT clinic, because they do bladder, bowel movement, and constipation management, it is harder to manage if the patient is not potty trained. Therefore, we are excluding participants under 2 years of age.
研究组 & 干预措施
Probiotic with or without antibiotic
Experimental
All patients will receive probiotics for this, only those with a UTI will get ciprofloxacin.
干预措施: Saccharomyces Boulardii 250 MG [Florastor] (Drug)
Control
No Intervention
Patients will get standard of care treatment.
结局指标
主要结局
Reduction in UTI episodes
时间窗: 6 months
We will look for a reduction the number of UTI episodes before and after the intervention.
次要结局
未报告次要终点
研究者
Mehreen Arshad
Assistant Professor
Ann & Robert H Lurie Children's Hospital of Chicago
研究点 (1)
Loading locations...
相似试验
终止
1 期
Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord InjuryUrinary Tract InfectionsSpinal Cord InjuryNCT00594594Lawson Health Research Institute2
已完成
不适用
The Efficacy of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy ChildrenAcute Upper Respiratory Tract Infections (Common Cold)NCT02640352Probi AB550
进行中（未招募）
3 期
Probiotic Saccharomyces boulardii for the prevention of antibiotic-associated diarrhoea. Randomised, double-blind, placebo-controlled trialantibiotic-associated diarrhoeaA04.7Enterocolitis due to Clostridium difficileDRKS00000084Bernhard-Nocht-Institut für Tropenmedizin477
进行中（未招募）
不适用
Probiotic Saccharomyces boulardii for the prevention of antibiotic-associated diarrhoeaAntibiotic - associated - Diarrhoea (AAD)Clostridium difficile - associated - Diarrhoea (CDAD)MedDRA version: 14.1Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10006835Term: C.difficile diarrhoeaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10055956Term: Antibiotic-associated diarrhoeaSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2009-017374-20-DEBernhard-Nocht-Institute for Tropical Medicine1,520
终止
4 期
Probiotics and the Prevention of Traveler's DiarrheaTravelers' DiarrheaNCT01005849Lallemand SAS420