Bovine Colostrum Supplementation for Prophylaxis Against Recurrent Urinary Tract Infection in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of UTIs with urinary bacterial colony count through urinary catheter > 10,000 CFU/ml having fever and pyuria
研究概览
简要总结
Prebiotics as bovine colostrum are considered as a valuable supplement in the prevention of upper respiratory tract infections, gastrointestinal tract infections and neonatal sepsis. It contains many bioactive substances, such as immunoglobulins, lactoferrin, lysozyme, lactoperoxidase, and other growth factors.There is a lack of research on the use of prebiotics for prophylaxis against recurrent urinary tract infection (UTI) in children.In this era of increasing bacterial resistance to antimicrobial therapy, bovine colostrum can offer an approach for prophylaxis against UTI in these patients.We aim at this trial to evaluate the efficacy and safety of bovine colostrum as a prebiotic for prophylaxis against recurrent urinary tract infection in children.
详细描述
This prospective,randomized, placebo-controlled pilot study will enroll a total of sixty children diagnosed with recurrent UTI and following up in Pediatric Nephrology Clinic at Children's Hospital at Ain Shams University. Participants' parents will sign an informed consent statement prior to inclusion in the study. Children fulfilling the eligibility criteria, whether they are already on antibiotic prophylaxis for UTI or not, will be randomly assigned (1:1), using a computer-generated list into one of two groups: Experimental group receiving oral Bovine colostrum sachets daily for 1 month (n=30)& Control group receiving oral placebo sachets daily for the same duration(n=30).
- Patient demographics, clinical symptoms suggestive of UTI, medication history, any risk factors for UTI, and clinical examination will be obtained at baseline.These will be followed up monthly for 6 months after the beginning of the study either during clinic visits or via telephone calls.
- Urine analysis (UA) will be done at base line, and monthly for 6 months. However if symptoms suggestive of UTI, UA will be requested.
- Urine culture at base line and with the appearance of symptoms or presence of pyuria in the urine analysis defined by > 10 WBC /HPF.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented recurrent UTI proven by positive urine culture. Recurrent UTI will be defined according to NICE guidelines as any of the following:
- •2 or more episodes of UTI with acute pyelonephritis.
- •1 episode of UTI with acute pyelonephritis plus 1 or more episode of UTI with cystitis.
- •3 or more episodes of UTI with cystitis.
排除标准
- •Allergy or hypersensitivity to the prescribed prebiotic.
- •Presence of any endo-urinary device (ureteral stent).
- •Presence of urinary stones
研究组 & 干预措施
Bovine Colostrum group
Thirty Patients will receive oral bovine colostrum sachets daily for one month in a dose of 1 sachet per day for children less than 2 years and 2 sachets per day for children older than 2 years.They will be instructed to take each sachet on an empty stomach at least 30 min before meals after being added to 50 ml of neutral (previously boiled) water with continuous mixing until being dissolved.
干预措施: Bovine colostrum (Dietary Supplement)
Control group
Thirty Patients will receive oral placebo sachets daily in a similar dose for the same duration. They will be instructed to receive it similarly to the experimental group.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of UTIs with urinary bacterial colony count through urinary catheter > 10,000 CFU/ml having fever and pyuria
时间窗: 6-months follow-up period.
European guidelines state that growth of 10,000 CFU/mL or even 1,000 CFU/ml are sufficient to diagnose a UTI from a catheterized urine while US and Canadian guidelines use 50,000 CFU/mL as the cut-off
Number of symptomatic UTIs
时间窗: 6-months follow-up period.
defined as the presence of bacteriuria (bacterial colony count ≥100,000 through clean catch method or ≥ 50000 CFU/ml through urinary catheter, IN COMBINATION with the presence of at least 1 acute (\<48 hours) clinical sign of infection (fever, shivers, vomiting, loin pain, dysuria, heamturia). Data regarding the type of UTI and the causative organism will be reported.
次要结局
- Number of patients with asymptomatic bacteruria(6-months follow-up period.)
- Number of asymptomatic patients with bacterial colony count > 10.000 CFU/ml and< 50,000 for specimen collected by urinary catheter.(6-months follow-up period.)
- Number of symptomatic infections elsewhere GIT/respiratory(6-months follow-up period.)
- Adverse effects to the prescribed bovine colostrum: GIT problems or allergy(6-months follow-up period.)
研究者
Noha Usama Hashem
lecturer of Pediatrics, Nephrology Department
Ain Shams University