Effect of the three-drug regimen of H. Pylori eradication with and without probiotics on the eradication treatment: a double-blind randomized clinical trial
To assess the effect of the three-drug regimen of H. Pylori eradication with and without probiotics on the eradication treatment
Design
This is a double-blind randomized clinical trial, phase II, in which 150 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with H. Pylori infection referring to the Shahid Beheshti 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 the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
H. pylori infection,
Exclusion criteria:
Pregnancy or breastfeeding,
Gastric cancer,
Kidney or liver failure,
History of gastric surgery,
Previous history of Helicobacter pylori treatment
Intervention groups
Intervention group:
Amoxicillin capsule 1000 mg (manufactured by Dana Pharmaceuticals Co.) every 12 hours for 12 weeks, and Clarithromycin tablet 500 mg (manufactured by Dana Pharmaceuticals Co.) every 12 hours for 12 weeks, and omeprazole capsule 20 mg (manufactured by Dana Pharmaceuticals Co.) every 12 hours For 12 weeks, and Probiotics Balance Probiotics capsule (British Made) every 12 hours for 2 weeks
Control group:
Amoxicillin capsule 1000 mg (manufactured by Dana Pharmaceuticals Co.) every 12 hours for 12 weeks, and Clarithromycin tablet 500 mg (manufactured by Dana Pharmaceuticals Co.) every 12 hours for 12 weeks, and omeprazole capsule 20 mg (manufactured by Dana Pharmaceuticals Co.) every 12 hours For 12 weeks
Main outcome variables
Primary outcome:
H. Pylori eradication
Secondary outcome:
Assessing gastrointestinal complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N344
Registration date:2020-03-09, 1398/12/19
Registration timing:retrospective
Last update:2020-03-09, 1398/12/19
Update count:0
Registration date
2020-03-09, 1398/12/19
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
2018-09-23, 1397/07/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the three-drug regimen of H. Pylori eradication with and without probiotics on the eradication treatment: a double-blind randomized clinical trial
Public title
Effect of the three-drug regimen of H. Pylori eradication with and without probiotics on the eradication treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
H. pylori infection,
Exclusion criteria:
Pregnancy or breastfeeding,
Gastric cancer,
Kidney or liver failure,
History of gastric surgery,
Previous history of Helicobacter pylori treatment,
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs will be given in coded envelops. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
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
2018-09-01, 1397/06/10
Ethics committee reference number
IR.UMSHA.REC.1397.402
Health conditions studied
1
Description of health condition studied
H. Pylori infection
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
Primary outcomes
1
Description
H. Pylori eradication
Timepoint
12 weeks after the intervention
Method of measurement
By respiratory urease test
Secondary outcomes
1
Description
Assessing gastrointestinal complications
Timepoint
12 weeks after the intervention
Method of measurement
By taking history
Intervention groups
1
Description
Intervention group: Amoxicillin capsule 1000 mg (manufactured by Dana Pharmaceuticals Co.) every 12 hours for 12 weeks, and Clarithromycin tablet 500 mg (manufactured by Dana Pharmaceuticals Co.) every 12 hours for 12 weeks, and omeprazole capsule 20 mg (manufactured by Dana Pharmaceuticals Co.) every 12 hours For 12 weeks, and Probiotics Balance Probiotics capsule (British Made) every 12 hours for 2 weeks
Category
Treatment - Drugs
2
Description
Control group: Amoxicillin capsule 1000 mg (manufactured by Dana Pharmaceuticals Co.) every 12 hours for 12 weeks, and Clarithromycin tablet 500 mg (manufactured by Dana Pharmaceuticals Co.) every 12 hours for 12 weeks, and omeprazole capsule 20 mg (manufactured by Dana Pharmaceuticals Co.) every 12 hours For 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamadan city
Full name of responsible person
Zahra Rahkoy
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
zahra.rahkoy@gmail.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
Zahra Rahkoy
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahra.rahkoy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza kHalilian
Position
Internist
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
khalilian@umsha.ac.ir
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