Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children

Last updated: December 2, 2023
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

2

Condition

Urinary Tract Infections

Treatment

Placebo

Bovine colostrum

Clinical Study ID

NCT06164600
FMAUS MS 2444/2023
  • Ages < 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented recurrent UTI proven by positive urine culture. Recurrent UTI will bedefined 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 withcystitis.
  3. 3 or more episodes of UTI with cystitis.

Exclusion

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 Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 01, 2023
Estimated Completion Date:
March 31, 2024

Study 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.

Connect with a study center

  • Ain Shams University Pediatric Hospital

    Cairo, Abbasseiya
    Egypt

    Active - Recruiting

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