Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic on the Urinary Tract Microbiota in Women With Recurrent Urinary Tract Infections (rUTI).
概览
- 阶段
- 不适用
- 干预措施
- Probiotic
- 疾病 / 适应症
- Recurrent Urinary Tract Infection
- 发起方
- ProbiSearch SL
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Evaluate the number of participants with a positive urine culture
- 状态
- 进行中（未招募）
- 最后更新
- 19天前
概览
简要总结
Urinary tract infections (UTIs) are the most common bacterial infections in women. 50% of women experiencing at least one UTI in their lifetime with an annual prevalence of 0.5-0.7%.
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strains on the urinary tract microbiota in participants with recurrent urinary tract infection (rUTI).
The study duration will be 6 and a half months, including 6 months product intake. Participants will be randomly assigned to one of the three study groups: control group with placebo administration, probiotic administration group (1 dose) and probiotic administration group (2 doses).
研究者
入排标准
入选标准
- •Adult women with aged between 18 and 65 years old, diagnosed with recurrent UTI (defined as at least two episodes during the last six months or three during the last 12 months).
- •Diagnosed, the last 7days, for a new UTI episode.
- •Written informed consent signed.
排除标准
- •Pregnant, breastfeeding or planning to become pregnant during the study.
- •Congenital abnormalities of the urinary tract.
- •Renal functional alterations, such as neurogenic bladder or vesicoureteral reflux.
- •Relevant renal disorders, such as interstitial cystitis, renal lithiasis, renal failure, kidney transplantation, pyelonephritis, renal nephropathy, etc.
- •Permanent catheter.
- •Immunocompromised (eg: cancer and/or transplant, patients who are taking immunosuppressive drugs, patients with hereditary diseases that affect or may affect the immune system).
- •Type I diabetes.
- •With a defect in the intestinal epithelium barrier (eg: chronic diarrhea, inflammatory bowel disease).
- •Heart failure and cardiac medical history (eg, artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation).
- •Under antibiotics prophylactic treatment without willingness to leave it at the time of inclusion.
研究组 & 干预措施
Probiotic
2 Capsule daily containing approximately 1\*10E9 colony forming unit (CFU) of Lactobacillus CECT 9422 +1\*10E9 colony forming unit (CFU) of Bifidobacterium CECT 30257.
干预措施: Probiotic
Probiotic + placebo
One capsule daily containing approximately 1\*10E9 colony forming unit (CFU) of Lactobacillus CECT 9422 +1\*10E9 colony forming unit (CFU) of Bifidobacterium CECT 30257 and 1 capsule of placebo supplement.
干预措施: Probiotic + placebo
Placebo
Two capsules daily of Placebo supplement.
干预措施: Placebo
结局指标
主要结局
Evaluate the number of participants with a positive urine culture
时间窗: After 6 months of intervention.
The number of participants with a positive urine culture will be compared between groups of treatment.
Evaluate the total bacterial count in urine samples.
时间窗: After 6 months of intervention
The total bacterial count in urine samples will be compared between groups of treatment.
Evaluate the number of participants with a positive urine culture
时间窗: Before intervention
The number of participants with a positive urine culture will be compared between groups of treatment.
Evaluate the number of participants with a positive urine culture
时间窗: After 3 months of intervention.
The number of participants with a positive urine culture will be compared between groups of treatment.
Evaluate the total bacterial count in urine samples.
时间窗: Before intervention
The total bacterial count in urine samples will be compared between groups of treatment.
Evaluate the total bacterial count in urine samples.
时间窗: After 3 months of intervention
The total bacterial count in urine samples will be compared between groups of treatment.
次要结局
- Elapsed time between the 2nd and 3rd episode of UTI.(After 6 months of intervention.)
- Duration of UTI episodes.(After 6 months of intervention.)
- Number of participants with pollakiuria(After 6 months of intervention.)
- Duration of pelvic pain(After 6 months of intervention.)
- Duration of pollakiuria(After 6 months of intervention.)
- Number of antibiotic treatments administered during new UTI episodes.(After 6 months of intervention.)
- Metabolomic profile of urine samples.(After 6 months of intervention.)
- Elapsed time until the 1st episode of UTI.(After 6 months of intervention.)
- Elapsed time between the 1st and 2nd episode of UTI.(After 6 months of intervention.)
- Infection free participants (%)(After 6 months of intervention.)
- Number of UTI episodes(After 3 and 6 months of intervention.)
- Number of participants with fever (Tª ≥ 38ºC).(After 6 months of intervention.)
- The number of participants which associate sexual activity with the UTI episodes(After 6 months of intervention.)
- Number of participants with dysuria.(After 6 months of intervention.)
- Duration of urinary urgency.(After 6 months of intervention.)
- Number of participants with tenesmus.(After 6 months of intervention.)
- Number of present symptoms during new UTI episodes.(After 6 months of intervention.)
- Duration of dysuria.(After 6 months of intervention.)
- Number of participants with urinary urgency.(After 6 months of intervention.)
- Number of participants with pelvic pain(After 6 months of intervention.)
- Duration of tenesmus.(After 6 months of intervention.)
- Duration of hematuria(After 6 months of intervention.)
- Number of participants with hematuria.(After 6 months of intervention.)
- Number of participants with dyspareunia(After 6 months of intervention.)
- Duration of dyspareunia(After 6 months of intervention.)
- Number of antibiotics administered for the UTI episode.(After 6 months of intervention.)
- Duration of fever (Tª ≥ 38ºC).(After 6 months of intervention.)
- Number of participants with cloudy and smelly urine(After 6 months of intervention.)
- Duration of cloudy and smelly urine(After 6 months of intervention.)
- Duration of antibiotic treatments administered during new UTI episodes.(After 6 months of intervention.)
- Duration of antibiotic treatment for the UTI episode.(After 6 months of intervention.)
- Microbiome composition of stool samples determined by 16S sequencing.(After 6 months of intervention.)
- Microbiota composition of urine samples determined by culture techniques.(After 6 months of intervention.)