Study of a Food Supplement (Mannose and Proanthocyanidins Prolonged Release 24h) Versus Proanthocyanidins in the Prevention of Urinary Tract Infections in Kidney Transplant Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change on the incidence of urinary tract infections.
研究概览
简要总结
The incidence of Urinary tract infections (UTIs) is very high in kidney transplant patients. Most UTIs occur during the first six months (82% within the first three months) of kidney transplantation and are frequently recurrent. The component D-mannose of our authorized food supplement acts by inhibiting the adherence of E.coli to the urothelium. It also has a controlled release formula that ensures the presence in urine of D-mannose and the other components during 24 hours. This is the reason why this experimental study aims to demonstrate that the oral intake of this food supplement is effective in the prevention of UTIs in kidney transplant patients.
详细描述
The study tries to analyze the impact of a food supplement (Manosar®) on the incidence of urinary infections in patients undergoing kidney transplantation.
The patients will be randomly distributed (1: 1 ratio) into two treatment groups of 30 patients each. In one group, they will be treated with Manosar®, and in the other group they will be treated with Proanthocyanidins. All patients will be followed for 6 months, being the first three months of the study drug administration.
This experimental study is double-blinded and there are 7 monthly study visits. Properties of D-mannose and Proanthocyanidins make interesting to evaluate the clinical benefit of the use of food supplements with D-mannose and Proanthocyanidins in order to prevent the UTIs without antibiotics.
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
- Double (Participant, Investigator)
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
- •≥ 18 years.
- •Recipients of a cadaveric donor kidney transplant.
- •Patients who are trained to give their informed consent.
排除标准
- •Recipients of a kidney transplant who do not authorize their participation in the study by informed consent.
- •Recipients of a transplant of an organ other than the kidney.
- •Patients with Bricker or Studer neobladders.
- •Patients in need of intermittent self-catheterization prior to kidney transplantation.
- •Any medical, psychiatric or family condition that, in the opinion of the investigator, may endanger or compromise the patient's ability to participate in the study.
- •Pregnant or lactating patients.
- •Having participated in clinical trials in the previous 3 months or participating in another clinical study promoted by the pharmaceutical industry, in which the promoter already establishes the treatment for UTI.
结局指标
主要结局
Change on the incidence of urinary tract infections.
时间窗: Baseline to 1, 2, 3, 4, 5 and 6 months
To assess the magnitude of the change from baseline incidence of urinary tract infections in kidney transplant patients at one month, two months and three months of treatment and at four, five and six months of follow-up.
次要结局
- Rate of patients who developed bacteremia during the episode of pyelonephritis.(Baseline to all study visits up to 6 months.)
- Rate of bacterial colonization of the double J catheter in both treatment groups.(From Visit 0 to Visit 1, up to 1 month.)
- Change from baseline in both treatment groups of concentration of potassium in renal function.(Baseline to all study visits up to 6 months.)
- Type of bacterial colonies of the double J catheter(From Visit 0 to Visit 1, up to 1 month.)
- Change from baseline in both treatment groups of concentration of serum creatinine in renal function.(Baseline to all study visits up to 6 months.)
- Rate of three types of urinary tract infection: asymptomatic bacteriuria, cystitis, and pyelonephritis between both treatment groups.(Baseline to all study visits up to 6 months.)
- Rate of histologically confirmed acute rejection and number of patients who lost the kidney graft.(Baseline to all study visits up to 6 months.)
- Rate of urinary tract infections caused by E.coli.(Baseline to all study visits up to 6 months.)
- Rate of safety episodes between both treatment groups.(From Visit 1, and at each visit, up to 6 months.)
- Rate of incidence of delayed renal graft function.(From Visit 0 to Visit 1, up to 1 month.)
- Change from baseline in both treatment groups of concentration of glucose in renal function.(Baseline to all study visits up to 6 months.)
- Change from baseline in both treatment groups of concentration of Glomerular Filtration Rate (GFR).(Baseline to all study visits up to 6 months.)
- Change from baseline in both treatment groups of concentration of sodium in renal function.(Baseline to all study visits up to 6 months.)