Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Bovine Colostrum Supplementation for Prophylaxis Against Recurrent Urinary Tract Infection in Children

Conditions
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Infections, Urinary Tract Infections, Recurrent, Child, Prevention & Control, Urologic Diseases, Communicable Diseases

Intervention / Treatment
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* Dietary Supplement: Bovine colostrum
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Allergy or hypersensitivity to the prescribed prebiotic. Presence of any endo-urinary device (ureteral stent). Presence of urinary stones

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bovine Colostrum group<br>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. | Dietary Supplement: Bovine colostrum<br>* A powdered form of the first 6 hours bovine colostrum [65 mg lactoferrin, lactoperoxidase: 2.8 unit and immunoglobulins in the form of 350 mg IgG, 35.3 mg of Ig A and 25.3 mg Ig M]<br>* Other names: ImmuGuard®;|
| Placebo Comparator: Control group<br>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. | Drug: Placebo<br>* Oral placebo sachets will be provided by ImmuGuard® manufacturing company.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of symptomatic UTIs | 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. | 6-months follow-up period. | 
| Number of UTIs with urinary bacterial colony count through urinary catheter > 10,000 CFU/ml having fever and pyuria | 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 | 6-months follow-up period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with asymptomatic bacteruria | defined as asymptomatic patients having bacterial colony count : 100,000 CFU/ml through clean catch method OR 50,000 CFU/ml through urinary catheter | 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. | Since the strict definition of bacterial colony count in UTI is operational and not absolute, the Italian Society of Pediatric nephrology issued guidelines recommended the threshold for specimen collected by catheterization to be >50.000 CFU/mL5, Or >10.000 CFU/mL if fever and leucocyturia are present. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bovine Colostrum