Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06164600
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-12-02
Brief Title:
Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Bovine Colostrum Supplementation for Prophylaxis Against Recurrent Urinary Tract Infection in Children
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 factorsThere is a lack of research on the use of prebiotics for prophylaxis against recurrent urinary tract infection UTI in childrenIn this era of increasing bacterial resistance to antimicrobial therapy bovine colostrum can offer an approach for prophylaxis against UTI in these patientsWe 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 prospectiverandomized placebo-controlled pilot study will enroll a total of sixty children diagnosed with recurrent UTI and following up in Pediatric Nephrology Clinic at Childrens 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 11 using a computer-generated list into one of two groups Experimental group receiving oral Bovine colostrum sachets daily for 1 month n30 Control group receiving oral placebo sachets daily for the same durationn30
Patient demographics clinical symptoms suggestive of UTI medication history any risk factors for UTI and clinical examination will be obtained at baselineThese 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
Patient demographics clinical symptoms suggestive of UTI medication history any risk factors for UTI and clinical examination will be obtained at baselineThese 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None