The Effect of ASTARTE™; Lactobacillus Crispatus, Lactobacillus Rhamnosus, Lactobacillus Jenesii and Lactobacillus Gasseri on the Reduction of Risk Factors for Recurrent Urinary Tract Infection in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- Reduction of UTI cases
研究概览
简要总结
Investigate the effect of dietary supplements/probiotic ASTARTE™ ( L. crispatus, L. rhamnosus, L. jensenii, L. gasseri) on the microbiome composition in the intestine and vagina and thereby a reduction of risk factors for the development of rUTI during 6 months of intervention in women aged 18-40 years. This is measured by the incidence of symptomatic UTI.
详细描述
Urinary tract infection (UTI) is one of the most common infections, contributing to increased antibiotic consumption and high costs. Women are often developing UTI due to the anatomically short distance from the rectum opening to the urethra. There is a risk of serious complications associated with pregnancy, where there is an increased risk of developing pelvic inflammatory disease and premature birth. This will in some cases lead to increased risk of maternal and neonatal morbidity and mortality; especially in infection with Streptococcus agalactiae. Recurrent UTI (rUTI) with urease producing microorganisms such as Proteus and Klebsiella will cause an increased risk of developing stones in the urinary tract.
Scientific studies suggest that probiotics can be effective dietary supplements reducing the risk factors for the development of infections in the intestine and vagina. Probiotics are non-pathogenic microorganisms capable of affecting gastrointestinal microbiota with a change in microbiota composition, thus increasing the production of beneficial substances when ingested in appropriate quantities. The consumption of probiotics is not considered to be associated with adverse reactions to humans because they are usually found naturally in e.g. gastrointestinal and vaginal microbiota.
A prospective study over 2-years which is conducted as a randomized placebo-controlled double-blind study. In this study the investigators will investigate the effect of probiotics ASTARTE™ ( Lactobacillus crispatus, Lactobacillus rhamnosus, Lactobacillus jensenii, Lactobacillus gasseri) on the composition of bacteria in urine, faces and vagina, and a possible reduction of risk factors for development of rUTI in women (18 to 40 years). The investigators will map the microbiota in the faeces and vagina and examine if there are a relationship between colonization of the urinary tract with pathogens and the composition of the intestinal and vaginal microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18-40 years of age
- •Recurrent UTI (2 times UTI within 6 months or > 3 times UTI infection within one year).
- •The subjects should be informed about the trial protocol.
- •The subject must be able to follow the protocol, have provided voluntary consent and have signed the declaration of consent.
排除标准
- •Pregnancy or planning pregnancy
- •Breastfeeding
- •Participation in another trial with probiotic the last 30 days.
- •Hypersensitivity to any ingredient in the study product
- •Patients primarily admitted for a disorder other than UTI
- •Antibiotic treatment for any other condition than UTI at time of recruitment the last 30 days
结局指标
主要结局
Reduction of UTI cases
时间窗: 6 months
Number of symptomatic urinary tract infection cases during the intervention compared to the number of UTI cases before the intervention (\> 2 UTIs per year). Measured from a urine sample.
次要结局
- Number of UTI after intervention(12 months)
- Change of vaginal microbiome(6 months)
- UTI symptoms(12 months)
- Change of gut microbiome(6 months)
研究者
Andreas Munk Petersen
MD, Associate Professor, PhD
Hvidovre University Hospital