Comparative study of prophylactic effect of probiotic versus placebo on the urinary tract infection in children with the first simple urinary tract infection
Comparative study of prophylactic effect of probiotic and placebo on the incidence of urinary tract infection in children with the first simple urinary tract infection will admitted & refer to pediatric urgence & ward at Khalij Fars Hospital in Bushehr 2019-2020
Design
A clinical trial with 94 patients in two groups; with control group; with parallel groups and unblinded study
Settings and conduct
This will be a prospective, descriptive-analytical study.
Children 1 to 12 years of age after recovery from febrile UTI are included in this study.
Patients in the probiotic group, daily probiotic containing:
109 colony-forming unit (CFU) (0.5g) / 10 mL of Lactobacillus and Bifidobacterium strains 0.5 mL (25 mg) / kg
They receive twice daily (maximum daily dose 20 mL / 1.0g) and patients in the placebo group consume the same amount of water.
For this purpose, the contents of each 500 mg capsule are dissolved in 10 ml of sterile water and placed in packs of 100, 200 and 300 cc. (The bacterial count does not change at 10 degrees for 4 weeks.) It is recommended to keep it in the refrigerator.
The urine sample is then sent monthly for 6 months via a suprapubic or catheter, with sterile conditions, for urine analysis and culture. If Kant's colony grows, there will be more than 100,000 urinary tract infections.
Participants/Inclusion and exclusion criteria
All 1 to 12 years old children with the first simple urinary tract infection with positive urine culture except for recurrent cases or urinary system abnormalities.
Intervention groups
One group as probiotic recipient to evaluate prophylactic effect and the other group as control with placebo.
Main outcome variables
These studie's findings can be an effective method for prevention of urinary tract infection in children by evaluating the prophylactic effect of probiotics on urinary tract infection and comparing it with placebo.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200202046347N1
Registration date:2020-03-20, 1399/01/01
Registration timing:registered_while_recruiting
Last update:2020-03-20, 1399/01/01
Update count:0
Registration date
2020-03-20, 1399/01/01
Registrant information
Name
Mohamadsaber Moghateli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3354 8936
Email address
saber.moghateli@mailfa.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-11, 1398/12/21
Expected recruitment end date
2020-04-09, 1399/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of prophylactic effect of probiotic versus placebo on the urinary tract infection in children with the first simple urinary tract infection
Public title
Comparative study of prophylactic effect of probiotic versus placebo on the urinary tract infection in children with the first simple urinary tract infection will admitted & refer to pediatric urgence & ward at Khalij Fars Hospital in Bushehr 2019-2020
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All of 1 to 12 years old children with non-complicated urinary tract infection with positive urine culture
Exclusion criteria:
Age
From 1 year old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization and individual units; statistical software; how to allocate people to two groups by quadruple block method using R software (considering block size: 4 and list length: 94), the target sequences were assigned to two groups . Group A was considered as control group and group B as intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Boushehr University of Medical Science, Salman Farsi St., Sabzabad Blvd., Boushehr, Iran
City
Boushehr
Province
Boushehr
Postal code
7518759577
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
IR.BPUMS.REC.1398.134
Health conditions studied
1
Description of health condition studied
Preventive effect of probiotic on recurrent urinary tract infection in children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Comparison of the prophylactic effect of probiotic and placebo on the incidence of urinary tract infection in children with the first simple urinary tract infection
Timepoint
Monthly for six months.
Method of measurement
Take urine samples with sterile conditions using a catheter and send them to the laboratory.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Probiotics recipient; In this group all subjects use probiotic substance called Prokid (developed by Gostaresh Milad Farmed), during that the contents of a capsule dissolve in water every night for six months and then drink it. This will be taught to persons by specialized expertise.
Category
Prevention
2
Description
Control group: Placebo recipient; In this group all subjects use water instead and drink water every night for six months. This will be taught to persons by specialized expertise.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalij Fars Hospital
Full name of responsible person
Dr Khadijeh Ghasemi
Street address
Khalij Fars Hospital, Taleghani St., Boushehr, Iran
City
Boushehr
Province
Boushehr
Postal code
7514933159
Phone
+98 77 3345 5381
Email
sabermoghateli@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr Azam Amini
Street address
University of Medical Sciences, Moallem St., Bandar Quarter, Boushehr, Iran
City
Boushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3332 2081
Email
sabermoghateli@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?