Clinical trial NCT06164600: Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children
Official title: Bovine Colostrum Supplementation for Prophylaxis Against Recurrent Urinary Tract Infection in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Urinary Tract Infections
Recurrent
Child
Prevention & Control
Infections
Urologic Diseases
Communicable Diseases
Keywords: Bovine Colostrum
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 60
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: Inclusion Criteria:

* Documented recurrent UTI proven by positive urine culture. Recurrent UTI will be defined 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 with cystitis.
  3. 3 or more episodes of UTI with cystitis.

Exclusion Criteria:

1. Allergy or hypersensitivity to the prescribed prebiotic.
2. Presence of any endo-urinary device (ureteral stent).
3. Presence of urinary stones

Primary outcomes:
measure: Number of symptomatic UTIs
timeFrame: 6-months follow-up period.
measure: Number of UTIs with urinary bacterial colony count through urinary catheter > 10,000 CFU/ml having fever and pyuria
timeFrame: 6-months follow-up period.
Secondary outcomes:
measure: Number of patients with asymptomatic bacteruria
timeFrame: 6-months follow-up period.
measure: Number of asymptomatic patients with bacterial colony count > 10.000 CFU/ml and< 50,000 for specimen collected by urinary catheter.
timeFrame: 6-months follow-up period.
measure: Number of symptomatic infections elsewhere GIT/respiratory
timeFrame: 6-months follow-up period.
measure: Adverse effects to the prescribed bovine colostrum: GIT problems or allergy
timeFrame: 6-months follow-up period.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Pediatric Hospital
state: Abbasseiya
Study officials:
References:
citation: Ammenti A, Alberici I, Brugnara M, Chimenz R, Guarino S, La Manna A, La Scola C, Maringhini S, Marra G, Materassi M, Morello W, Nicolini G, Pennesi M, Pisanello L, Pugliese F, Scozzola F, Sica F, Toffolo A, Montini G; Italian Society of Pediatric Nephrology. Updated Italian recommendations for the diagnosis, treatment and follow-up of the first febrile urinary tract infection in young children. Acta Paediatr. 2020 Feb;109(2):236-247. doi: 10.1111/apa.14988. Epub 2019 Oct 6.
citation: Ammenti A, Cataldi L, Chimenz R, Fanos V, La Manna A, Marra G, Materassi M, Pecile P, Pennesi M, Pisanello L, Sica F, Toffolo A, Montini G; Italian Society of Pediatric Nephrology. Febrile urinary tract infections in young children: recommendations for the diagnosis, treatment and follow-up. Acta Paediatr. 2012 May;101(5):451-7. doi: 10.1111/j.1651-2227.2011.02549.x. Epub 2012 Jan 3.
citation: Robinson JL, Finlay JC, Lang ME, Bortolussi R; Canadian Paediatric Society, Infectious Diseases and Immunization Committee, Community Paediatrics Committee. Urinary tract infections in infants and children: Diagnosis and management. Paediatr Child Health. 2014 Jun;19(6):315-25. doi: 10.1093/pch/19.6.315.
citation: Stein R, Dogan HS, Hoebeke P, Kocvara R, Nijman RJ, Radmayr C, Tekgul S; European Association of Urology; European Society for Pediatric Urology. Urinary tract infections in children: EAU/ESPU guidelines. Eur Urol. 2015 Mar;67(3):546-58. doi: 10.1016/j.eururo.2014.11.007. Epub 2014 Dec 2.