Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-08-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bovine Colostrum group

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.

Group Type EXPERIMENTAL

Bovine colostrum

Intervention Type DIETARY_SUPPLEMENT

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

Control group

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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