Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children

December 28, 2025 updated by: Noha Usama Hashem, Ain Shams University

Bovine Colostrum Supplementation 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasseiya
      • Cairo, Abbasseiya, Egypt
        • Ain Shams University Pediatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Documented recurrent UTI proven by positive urine culture. Recurrent UTI will be defined according to NICE guidelines as any of the following:

    1. 2 or more episodes of UTI with acute pyelonephritis.
    2. 1 episode of UTI with acute pyelonephritis plus 1 or more episode of UTI with cystitis.
    3. 3 or more episodes of UTI with cystitis.

Exclusion Criteria:

  1. Allergy or hypersensitivity to the prescribed prebiotic.
  2. Presence of any endo-urinary device (ureteral stent).
  3. Presence of urinary stones

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: Bovine colostrum
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 Comparator: 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.
Drug: Placebo
Oral placebo sachets will be provided by ImmuGuard® manufacturing company.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-months follow-up period.
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
6-months follow-up period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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.
6-months follow-up period.
Number of symptomatic infections elsewhere GIT/respiratory
Time Frame: 6-months follow-up period.
6-months follow-up period.
Adverse effects to the prescribed bovine colostrum: GIT problems or allergy
Time Frame: 6-months follow-up period.
6-months follow-up period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

August 20, 2024

Study Completion (Actual)

August 20, 2024

Study Registration Dates

First Submitted

December 2, 2023

First Submitted That Met QC Criteria

December 2, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMAUS MS 2444/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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