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NCT Number: NCT06164600

Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children

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.

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Key information

Conditions

Urinary Tract Infections Child Communicable Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prevention & Control Recurrence Recurrent Urogenital Diseases Urologic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams University Pediatric Hospital

Cairo, Abbasseiya, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bovine colostrum

Dietary Supplement

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]

Other names: ImmuGuard®

Placebo

Drug

Oral placebo sachets will be provided by ImmuGuard® manufacturing company.

Primary outcomes

  1. Number of symptomatic UTIs

    Time frame: 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.

  2. Number of UTIs with urinary bacterial colony count through urinary catheter > 10,000 CFU/ml having fever and pyuria

    Time frame: 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

Secondary outcomes

  1. Number of patients with asymptomatic bacteruria

    Time frame: 6-months follow-up period.

    defined as asymptomatic patients having bacterial colony count :

    • 100,000 CFU/ml through clean catch method OR
    • 50,000 CFU/ml through urinary catheter

  2. Number of asymptomatic patients with bacterial colony count > 10.000 CFU/ml and< 50,000 for specimen collected by urinary catheter.

    Time frame: 6-months follow-up period.

    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.

  3. Number of symptomatic infections elsewhere GIT/respiratory

    Time frame: 6-months follow-up period.

  4. Adverse effects to the prescribed bovine colostrum: GIT problems or allergy

    Time frame: 6-months follow-up period.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 11, 2023
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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