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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.
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.
Age
0 - 18 years
Sex
ALL
Healthy Volunteers
No
Ain Shams University Pediatric Hospital
Cairo, Abbasseiya, Egypt
Start Date
June 1, 2023
Primary Completion Date
August 20, 2024
Completion Date
August 20, 2024
Last Updated
January 2, 2026
60
ACTUAL participants
Bovine colostrum
DIETARY_SUPPLEMENT
Placebo
DRUG
Lead Sponsor
Ain Shams University
NCT05058651
NCT05488340
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