Effect of Helicobacter pylori eradication versus no eradication on disease period and treatment response in children with nephrotic syndrome: a randomized clinical trial
To assess the effect of Helicobacter pylori eradication versus no eradication on disease period and treatment response in children with nephrotic syndrome
Design
This is a randomized clinical trial, phase II, in which 48 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible children with nephrotic syndrome who will refer to Besat Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 2 to 14 years;
Nephrotic syndrome;
Helicobacter pylori positive
Exclusion criteria:
Glomerulonephritis;
Renal failure;
High blood pressure;
Using antibiotic or antacid in the past month
Intervention groups
Intervention group:
Corticosteroid tablet 60 mg/m2 daily for 2 years plus four-drug treatment for 2 weeks with omeprazole capsule 1 mg/kg daily and metronidazole tablet 20 mg/kg daily and ampicillin capsule 50 mg/kg daily and bismuth citrate tablet 480 mg/kg daily for
Control group:
Corticosteroid tablet 60 mg/m2 daily for 2 years
Main outcome variables
Primary outcome:
Assessing the proteinuria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N268
Registration date:2019-04-11, 1398/01/22
Registration timing:registered_while_recruiting
Last update:2019-04-11, 1398/01/22
Update count:0
Registration date
2019-04-11, 1398/01/22
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Helicobacter pylori eradication versus no eradication on disease period and treatment response in children with nephrotic syndrome: a randomized clinical trial
Public title
Effect of Helicobacter pylori eradication versus no eradication on disease period and treatment response in children with nephrotic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 2 to 14 years;
Nephrotic syndrome;
Helicobacter pylori positive
Exclusion criteria:
Glomerulonephritis;
Renal failure;
High blood pressure;
Using antibiotic or antacid in the past month
Age
From 2 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.UMSHA.REC.1397.959
Health conditions studied
1
Description of health condition studied
Nephrotic syndrome
ICD-10 code
N04
ICD-10 code description
Nephrotic syndrome
Primary outcomes
1
Description
Assessing the proteinuria
Timepoint
At the end of the first, second and third months
Method of measurement
Through the laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Corticosteroid tablet 60 mg/m2 daily for 2 years plus four-drug treatment for 2 weeks with omeprazole capsule 1 mg/kg daily and metronidazole tablet 20 mg/kg daily and ampicillin capsule 50 mg/kg daily and bismuth citrate tablet 480 mg/kg daily for
Category
Treatment - Drugs
2
Description
Control group: Corticosteroid tablet 60 mg/m2 daily for 2 years
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan City
Full name of responsible person
Dr. Danyal Isapour
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
danyal-Isapour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@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
Dr. Danyal Isapour
Position
Resident of Pediatric
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
danyal-Isapour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Hasan Bazmamoun
Position
Podiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
hbazmamoun@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available