Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The number of UTI events in the follow-up period
研究概览
简要总结
Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.
We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.
详细描述
Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.
We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.
Claim to be investigated:
- The non-pathogenic bacterial strain (ABU) E.coli can overcome the most common pathogenic E.coli (UPEC) in humans.
- ABU can be used for preventive treatment in patients with recurrent urinary tract infections.
Clinical effect of preventive treatment (prophylactic treatment) with the non-pathogenic bacterial strain (ABU) in a selected group of patients with recurrent cystitis: A clinical, placebo-controlled, triple-blinded study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with recurrent cystitis including 2 times of rUTI within the last 6 months or 3 times in the last 12 months, where at least 2 cultures show the same bacteria.
- •Normal investigation for lower urinary tract diseases (LUTD) including voiding diary, symptom scores, flexible cystoscopy, voiding diagram and test for residual urine.
- •Failed previously treatments.
- •Patients with native bladder with both spontaneous voiding, the need for clean intermittent catheter (CIC) or indwelling catheter.
- •Patients with neurogenic and non-neurogenic bladder dysfunction.
- •Patients with urostomy, kidney transplantation or another complicated genesis.
- •Written consent.
排除标准
- •Malignancy in the urinary tract, kidney-, ureteral- or bladder stones, age < 18 years, pregnancy, breastfeeding. Patients in ongoing orally antibiotic treatment. Not able to speak or understand Danish.
研究组 & 干预措施
Patients prophylatic treated with ABU
Patients with prophylactic bladder flushing with an ABU strain.
干预措施: ABU bladder lavage (Biological)
Patients control group
The control group with bladder flushing with saline solution.
干预措施: Saline bladder lavage (Biological)
结局指标
主要结局
The number of UTI events in the follow-up period
时间窗: 1½ year
The number of prescriptions or hospital visits
次要结局
- Quality of life by standard Questionnaires_ICIQ-OABqol 08/04(1½ year)
- CRF(1½ year)
- Hospitalization(1½ year)
- Complications (bleeding, pain)(1½ year)
- Microbiological diagnostics: Etiology, resistance(1½ year)
- Natrium and kalium(1½ year)
- EQ-5D-5L(1½ year)
- Creatinin(1½ year)
- O´Leary-Sant Voiding and Pain symptom score(1½ year)
- Time to first UTI after the intervention(1½ year)
- Leukocytes and neutrofilocytes(1½ year)
- CRP(1½ year)
研究者
Karin Andersen
MD
Odense University Hospital