Protocol summary

Study aim
The role of probiotic in the medical care of children with VUR.
Design
All children from 2 months to 8 years old are included in the study according to the inclusion criteria. Patients who, according to the pediatric nephrologist, are candidates for medical treatment are randomly divided into two groups. The first group was treated with antibiotic prophylaxis, the second group was treated with probiotics
Settings and conduct
This one-year research will take place at Besat Hospital's nephrology clinic in Hamadan.After taking the history, physical examination, routine tests and necessary imaging examinations and grouping of patients, the protocols will be implemented.
Participants/Inclusion and exclusion criteria
Children aged 2 months to 8 years who have been diagnosed with VUR by a pediatric nephrologist. Exclusion criteria: Patients with obstructive causes of VUR, such as congenital obstructive uropathy and acquired obstructive causes of VUR, such as urinary stones and ureteral obstruction due to prior scarring, existence of infectious and inflammatory causes at the same time, any known immune system deficiency, whether congenital or acquired, some metabolic disorders that have been reported and parental dissatisfaction,.were excluded.
Intervention groups
Imaging criteria (grading reflux) and nuclear scan findings are used to nominate patients for medical or surgical care. Patients that are candidates for medical attention, according to the pediatric nephrologist, are classified into two classes at randomIn the case group (intervention) prescribing probiotics as prophylaxis., Probiotics. In the control group no probiotics and prophylaxis antibiotics..
Main outcome variables
Outcome of the disease is defined as recurrence of UTI or absence of UTI and the course of the disease will be compared in terms of response to treatment and the rate of recurrence within 1 year.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140810018747N1
Registration date: 2021-06-27, 1400/04/06
Registration timing: registered_while_recruiting

Last update: 2021-06-27, 1400/04/06
Update count: 0
Registration date
2021-06-27, 1400/04/06
Registrant information
Name
hassan bazmamoun
Name of organization / entity
Hamadan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3264 0062
Email address
bazmamoun@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of probiotic prophylaxis in children with vesicoureteral reflux referred to the pediatric nephrology ward of Hamadan’s Besat Hospital, Iran.
Public title
Evaluation of the effect of probiotic prophylaxis in children with vesicoureteral reflux
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All children 2 months to 8 years old who have been diagnosed with VUR by pediatric nephrologist based on imaging results
Exclusion criteria:
1.Patients with obstructive causes 2.The presence of concomitant infections and inflammation 3.The presence of any known immune system disorders ,whether congenital or acquired 4.The presence of any known metabolic disorders.
Age
From 2 months old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 800
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization method was used. Random units were children with vesicoureteral reflux. “Blockrand()” function in R statistical package was used to generate a block randomization for this clinical trial. This function will randomize subjects to the specified treatments within sequential blocks. Permuted Block Randomization (PBR) consists of 200 blocks with block length 4. Permuted Block Randomization with block length 4 is denoted by PBR(4). In each block of PBR(4) half of the patients are assigned to the treatment groups A and B, respectively. The realization of the above program is as follows: [antibiotic prophylaxis group (B) and probiotic therapy group (A)]
Blinding (investigator's opinion)
Single blinded
Blinding description
Control group with cephalexin capsule, which is odorless and cream-colored. The probiotic capsule treatment group is similar in structure, shape, color and odor to the control group and the drugs are indistinguishable in appearance. Due to the fact that patients are randomly assigned to groups, patients are not aware of the assigned treatment. In this study, participants enter the study based on designated blocks and without knowing the placement in groups. Patients are unaware of the placement in groups, but the facilitator (researcher) is aware of the placement and grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd.
City
Hamadan
Province
Hamadan
Postal code
6517838736.
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.UMSHA.REC.1400.117

Health conditions studied

1

Description of health condition studied
Vesicoureteral-reflux
ICD-10 code
N13.732
ICD-10 code description
Vesicoureteral-reflux with reflux nephropathy with hydroureter, bilateral

Primary outcomes

1

Description
Urinary tract infection recurrence in patients receiving prophylaxis
Timepoint
MONTHLY
Method of measurement
U/A,U/C

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Probiotic administration as prophylaxis, Yumogi probiotic {from Irianik company (Ardifarm Germany) containing Saccharomyces boulardii} with a dose of one 250 mg capsule at the bedtime .
Category
Prevention

2

Description
Control group: no probiotics and prophylaxis antibiotics, prophylaxis with cephalexin (Farabi Pharmaceutical Company) 10 mg per kg body weight, once a day at the bedtime .
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Nephrology Clinic of Besat Hospital, Hamadan
Full name of responsible person
Maryam Emamjamat
Street address
Besat Hospital, Hamadan, Shahid Motahari Boulevard
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3264 0044
Fax
+98 81 3264 0048
Email
dr2amiri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0426
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Hassan Bazmamoun
Position
Associate Professor of Pediatrics Gastroenterology Department of Pediatrics, School of Medicine Besa
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Hamadan Shahid Fahmideh Blvd. Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0426
Email
hbazmamoun@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Rahimpour Amiri
Position
Assistant Professor of Pediatric Nephrology Department of Pediatrics, School of Medicine Besat Hospi
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Hamadan Shahid Fahmideh Blvd. Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0426
Email
r.amiri@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Emamjamat
Position
Pediatric's resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Besat Hospital, Hamadan, Motahhari Boulevard
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3264 0050
Email
dr2amiri@gmail.com

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of this study are published in the title of the dissertation and the subsequent paper by Hamadan University of Medical Sciences.
When the data will become available and for how long
From 2023, access was provided.
To whom data/document is available
Researchers, physicians, nurses and medical students
Under which criteria data/document could be used
Use the findings to improve patient care and develop research strategies.
From where data/document is obtainable
Hamadan University of Medical Science
What processes are involved for a request to access data/document
Consult the Hamadan University of Medical Sciences' Central Library.
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