NCT06164600

Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Urinary Tract Infections
• Recurrent
• Child
• Prevention & Control
• Infections
• Urologic Diseases
• Communicable Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bovine colostrum	A powdered form of the first 6 hours bovine colostrum \[65 mg lactoferrin, lactoperoxidase: 2.8 unit and immunoglobulins in the form of 350 mg IgG, 35.3 mg of Ig A and 25.3 mg Ig M\]
DRUG	Placebo	Oral placebo sachets will be provided by ImmuGuard® manufacturing company.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-08-20
• Completion: 2024-08-20
• First posted: 2023-12-11
• Last updated: 2026-01-02

Locations

1 site across 1 country: Egypt