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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Ain Shams University Pediatric Hospital
RECRUITING
Cairo
Contact Information
Primary
Noha U Mohammed Hashem, PhD
usnoha@gmail.com
+201118982827
Backup
Ragia M Said, PhD
ragiamarei@gmail.com
+201001749634
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2024-03
Participants
Target number of participants: 60
Treatments
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.
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.
Sponsors
Leads: Ain Shams University

This content was sourced from clinicaltrials.gov