Determining the effect of probiotics in the treatment of urinary tract infections in children aged 6 months to 12 years hospitalized in Ayatollah Mousavi Hospital in Zanjan in the period of 2021-2022
Design
Clinical trial with control group, with parallel, randomized, phase 3 groups on 48 patients
Settings and conduct
This study is performed as a clinical trial for 48 patients aged 6 months to 12 years who will be admitted to the pediatric ward of Ayatollah Mousavi Hospital in Zanjan in 2021-2022 due to urinary tract infection as indicated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients 6 months to 12 years with diagnosis of urinary tract infection (urine analysis and positive urine culture), Lack of allergy of the patient to probiotic drug (pedilact), Willingness to participate in the study.
Exclusion criteria: renal abnormalities, Having any type of immunodeficiency, Having a UTI and another infectious disease at the same time, Emphysematous pyelonephritis, Allergy to probiotic drug (pedilact) or intolerance to it.
Intervention groups
An intervention group and a control group participated in this study. In the intervention group, in addition to routine treatments, they will receive probiotics for 5 days (5 drops per day for children under 2 years and 15 drops daily for children older than 2 years) and in the control group will receive only routine treatments.
Main outcome variables
Improve the symptoms of urinary tract infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211028052897N1
Registration date:2022-03-13, 1400/12/22
Registration timing:registered_while_recruiting
Last update:2022-03-13, 1400/12/22
Update count:0
Registration date
2022-03-13, 1400/12/22
Registrant information
Name
Mahsa Ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3342 2760
Email address
drmahsaansari.9022@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-31, 1400/08/09
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotics in the treatment of urinary tract infections in children 6 months to 12 years
Public title
The effect of probiotics in the treatment of urinary tract infections in children 6 months to 12 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients 6 months to 12 years with diagnosis of urinary tract infection (urine analysis and positive urine culture)
Lack of allergy of the patient to probiotic drug (pedilact)
Willingness to participate in the study
Exclusion criteria:
Renal anomalies
Having any type of immunodeficiency
Having a UTI and another infectious disease at the same time
Emphysematous pyelonephritis
Allergy to probiotic drug (pedilact) or intolerance to it
Age
From 6 months old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Samples Will be selected from 48 patients aged 6 months to 12 years with a diagnosis of urinary tract infection admitted to the pediatric ward in Ayatollah Mousavi Hospital, Zanjan University of Medical Sciences. Individuals are randomly divided into two groups receiving probiotic drug (pedilact) and the control group. Random allocation will be considered as Block permutation Randomization with four blocks including AABB-BBAA-BABA-ABAB-BAAB-ABBA and individuals will be assigned to intervention or control groups based on these blocks (which will be randomly selected).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Deputy of Research and Technology of Zanjan University of Medical Sciences
Street address
Deputy of Research and Technology, third floor, Second building, Central Headquarters of Zanjan University of Medical Sciences, The beginning of Jomhuri Eslami Boulevard, Azadi Blv, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.ZUMS.REC.1400.210
Health conditions studied
1
Description of health condition studied
Urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
Improve the symptoms of urinary tract infection
Timepoint
2 and 5 days after starting Probiotic treatment (pedilact)
Method of measurement
Urine culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine treatments , they will receive probiotics for 5 days (5 drops per day for children under 2 years and 15 drops daily for children older than 2 years).
Category
Treatment - Drugs
2
Description
Control group: They will only receive routine treatments that include intravenous ceftriaxone at a dose of 50 mg / kg / day to 75 mg / kg / day.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After completing the study, there is a plan to share non-identifiable individual data of the participants, the study protocol, the statistical analysis of the data, the informed consent form patents, clinical reports, analysis codes, and data coding systems (Dictionary).
When the data will become available and for how long
The start of the access period to the data of this study will be from Early 2023 and approximately 6 months after the publication of the results.
To whom data/document is available
The data of this study are possible for all Families of children have a urinary tract infection and are hospitalized in the pediatric ward, and especially those working in health care systems.
Under which criteria data/document could be used
The researcher wants to use the data to improve of children with urinary tract infections.
From where data/document is obtainable
To receive information anyone can be use the following email: moezi@zums.ac.ir
What processes are involved for a request to access data/document
After sending the message and introducing herself or himself and the reason for the need for data, the applicant will be provided with the information after confirmation.