This study emphasizes the prophylactic role of prophylactic probiotics or the reduction of recurrence of urinary tract infections.
Design
Patients who eligible for the study and make signed consent letter are randomly assigned to one of the two groups receiving probiotics or placebo. Patients are evaluated for Pyriorrhea (U / A) and Urinary Cultures (U / C). The urine culture test is positive for more than 10 ^ 4 colony of bacteria (urine culture> 10^ 5 was considered positive but considering that our patients were admitted to the ICU and the catheter The urine was considered to be> 10 ^ 4 positive.
Patients are randomly divided into two groups by using the envelope method:
Group A Prokid capsule (500mg) containing 3.5x 〖10〗 ^ 9 units Bifid bacterium lactys and 1x 〖10〗 ^ 9 lactobacillus acidophilus and 0.5x 〖10〗 ^ 9 lactobacillus rhamiosus and 1x 〖10〗 ^ 9 units of bifidobacterium bifidum. It is dissolved in water and delivered to the final dose 10 ^ 9 unit/ mL and taken at a dose of 0.5 mL / kg twice daily.
Patients in the control group B also receive 0.5 mL / kg of body weight twice a day in pure water.
Settings and conduct
A three-blind parallel study is conducted at Besat Hospital in Sanandaj.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children with acute pyelonephritis (fever above 38 degrees, leukocytosis over 10 thousand and positive culture) without a previous history, age 6 months to 13 years. renal ultrasound performed by a reliable radiologist, hydronephrosis, hypoplasia, cysts or reflux has not been reported.
Exclusion criteria: patient and parents dissatisfaction, lack of response to treatment within 48 hours
Intervention groups
Intervention group: Group A or study group are patients who receive probiotics . Control group: the B group or the control group are patients who receive placebo.
Main outcome variables
Recurrence of urinary tract infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141208020249N3
Registration date:2018-10-08, 1397/07/16
Registration timing:registered_while_recruiting
Last update:2018-10-08, 1397/07/16
Update count:0
Registration date
2018-10-08, 1397/07/16
Registrant information
Name
Behzad Khalafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3344 9697
Email address
khalafi.behzad70@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-17, 1397/03/27
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of probiotics role in the prevention of urinary tract infection relapse after the first acute uncomplicated pyelonephritis in children
Public title
The role of probiotics in urinary tract infections prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Acute pyelonephritis
Not history of urinary tract infections
Not having urinary re flux
Not having genitourinary system structural defects
6 month to 13 years old children
Exclusion criteria:
within 48 hours treatment response failure
patient and parents Dissatisfaction
Age
From 6 months old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Envelope contains codeBefore starting a study, a series of envelopes are prepared based on the code available on the drug containers. The investigator and the patient are not aware of the concept of the code until the end of the study. Patients will select a package randomly at the time of the first visit and receive the medication.
Blinding (investigator's opinion)
Double blinded
Blinding description
The medicines are packaged and encoded by a pharmacist out of study. Packages are delivered to the pharmacy for distribution to patients. The code on the packets remains outside the study until the analysis of the data is completed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
pasdaran Blvd, opposite Shadi Hotel, Kurdistan University of Medical Sciences, Sanandaj, Management of Medical Researches and Information. POB 6617713446
City
sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2018-08-19, 1397/05/28
Ethics committee reference number
IR.MUK.REC.1397.134
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
urinary tract reinfection within 6 months
Timepoint
6 month
Method of measurement
urine culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A or study group are patients who receive probiotics Group A Prokid capsule (500mg) containing 3.5x 〖10〗 ^ 9 units Bifid bacterium lactys and 1x 〖10〗 ^ 9 lactobacillus acidophilus and 0.5x 〖10〗 ^ 9 lactobacillus rhamiosus and 1x 〖10〗 ^ 9 units of bifidobacterium bifidum. It is dissolved in water and delivered to the final dose 10 ^ 9 unit/ mL and taken at a dose of 0.5 mL / kg twice daily.
Category
Treatment - Drugs
2
Description
Control group: the B group or the control group are patients who receive placebo.Patients in the control group B also receive 0.5 mL / kg of body weight twice a day in pure water.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Rama Naghshizadian
Street address
Vakil Crossroad, Besat Hospital, Department of pediatrric
City
Sanandaj
Province
Kurdistan
Postal code
000000000000
Phone
+98 87 3328 2004
Email
naderi.nooshafarin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Sanandaj, Kurdistan University of Medical Sciences, opposite Shadi Hotel, Kurdistan University of Medical Science, POB 6617713446 Management of medical research and information
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
khalafi.behzad70@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Research Associate, Researcher Soldier General Physician of Kurdistan University of Medical Scien
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Vice Chancellor in Research Affair, Kurdistan University of Medical Sciences, Pasdaran Ave. Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 45 3344 9697
Fax
+98 87 3366 4645
Email
khalafi.behzad70@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Rama Naghshidaian
Position
professor Asistant of Pediatric Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Besat Hospital, Vakil Crossroad , Sanandaj
City
sanandaj
Province
Kurdistan
Postal code
0000000000
Phone
+98 87 3328 2004
Email
R.nagshizadia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Research Associate, Researcher Soldier - General Physician of Kurdistan University of Medical Scien
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Vice Chancellor in Research Affair, Kurdistan University of Medical Sciences, Pasdaran Ave. Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 45 3344 9697
Fax
+98 87 3366 4645
Email
khalafi.behzad70@muk.ac.ir
Sharing plan
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
All data is from the proposal, raw data and project reports
When the data will become available and for how long
Data is available from the legal system six months after publication for two years
To whom data/document is available
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.
Under which criteria data/document could be used
For legal issues and the need to use data in future studies
From where data/document is obtainable
Rama Naghshizadian
What processes are involved for a request to access data/document
After submitting a request to the Kurdistan Research and Technology Dept. of Science and Technology, a call for submission is given.