Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164600
• Other study ID #: FMAUS MS 2444/2023
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2023
• Est. completion date: March 2024

Study information

• Verified date: December 2023
• Source: Ain Shams University
• Contact: Noha U Mohammed Hashem, PhD
• Phone: +201118982827
• Email: usnoha[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Pediatric Hospital	Cairo	Abbasseiya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of symptomatic UTIs	defined as the presence of bacteriuria (bacterial colony count =100,000 through clean catch method or = 50000 CFU/ml through urinary catheter, IN COMBINATION with the presence of at least 1 acute (<48 hours) clinical sign of infection (fever, shivers, vomiting, loin pain, dysuria, heamturia). Data regarding the type of UTI and the causative organism will be reported.	6-months follow-up period.
Primary	Number of UTIs with urinary bacterial colony count through urinary catheter > 10,000 CFU/ml having fever and pyuria	European guidelines state that growth of 10,000 CFU/mL or even 1,000 CFU/ml are sufficient to diagnose a UTI from a catheterized urine while US and Canadian guidelines use 50,000 CFU/mL as the cut-off	6-months follow-up period.
Secondary	Number of patients with asymptomatic bacteruria	defined as asymptomatic patients having bacterial colony count : 100,000 CFU/ml through clean catch method OR; 50,000 CFU/ml through urinary catheter	6-months follow-up period.
Secondary	Number of asymptomatic patients with bacterial colony count > 10.000 CFU/ml and< 50,000 for specimen collected by urinary catheter.	Since the strict definition of bacterial colony count in UTI is operational and not absolute, the Italian Society of Pediatric nephrology issued guidelines recommended the threshold for specimen collected by catheterization to be >50.000 CFU/mL5, Or >10.000 CFU/mL if fever and leucocyturia are present.	6-months follow-up period.
Secondary	Number of symptomatic infections elsewhere GIT/respiratory		6-months follow-up period.
Secondary	Adverse effects to the prescribed bovine colostrum: GIT problems or allergy		6-months follow-up period.

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