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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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] |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with asymptomatic bacteruria | defined as asymptomatic patients having bacterial colony count :
| 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. |
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Inclusion Criteria:
Documented recurrent UTI proven by positive urine culture. Recurrent UTI will be defined according to NICE guidelines as any of the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Pediatric Hospital | Cairo | Abbasseiya | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31454101 | Background | 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. | |
| 22122295 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D012008 | Recurrence |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Placebo | Drug | Oral placebo sachets will be provided by ImmuGuard® manufacturing company. |
|
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. |
| 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. |
| 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. |
| 25332662 | 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. |
| 25477258 | 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. |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |