Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children

NCT06164600 | Completed Phase 2 DMC

• 1 other identifier: FMAUS MS 2444/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections; Recurrent; Child; Prevention & Control; Infections; Urologic Diseases; Communicable Diseases

Keywords

Bovine Colostrum

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (4)

• Number of patients with asymptomatic bacteruria

  6-months follow-up period.

• Number of asymptomatic patients with bacterial colony count > 10.000 CFU/ml and< 50,000 for specimen collected by urinary catheter.

  6-months follow-up period.

• Number of symptomatic infections elsewhere GIT/respiratory

  6-months follow-up period.

• Adverse effects to the prescribed bovine colostrum: GIT problems or allergy

  6-months follow-up period.

Study Arms (2)

Bovine Colostrum group

EXPERIMENTAL

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.

Dietary Supplement: Bovine colostrum

Control group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Bovine colostrum DIETARY_SUPPLEMENT

A powdered form of the first 6 hours bovine colostrum \[65 mg lactoferrin, lactoperoxidase: 2.8 unit and immunoglobulins in the form of 350 mg IgG, 35.3 mg of Ig A and 25.3 mg Ig M\]

Also known as: ImmuGuard®

Bovine Colostrum group

Placebo DRUG

Oral placebo sachets will be provided by ImmuGuard® manufacturing company.

Control group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Documented recurrent UTI proven by positive urine culture. Recurrent UTI will be defined according to NICE guidelines as any of the following:
• or more episodes of UTI with acute pyelonephritis.
• episode of UTI with acute pyelonephritis plus 1 or more episode of UTI with cystitis.
• or more episodes of UTI with cystitis.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Pediatric Hospital

Cairo, Abbasseiya, Egypt

Location

Related 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.

  PMID: 31454101 BACKGROUND

• 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.

  PMID: 22122295 BACKGROUND

• 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.

  PMID: 25332662 BACKGROUND

• 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.

  PMID: 25477258 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Urinary Tract Infections; Recurrence; Infections; Urologic Diseases; Communicable Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Pediatrics, Nephrology Department

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 11, 2023
• Study Start: June 1, 2023
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: January 2, 2026

Record last verified: 2023-12

Locations

EG (1)