Eradication Efficacy of high dose amoxicillin and PPI Compared with standard bismuth containing quadruple Therapy as a First Line Treatment of Helicobacter pylori
evaluation of easier antibiotic treatment regimen with fewer side effects in H.pilori treatment
Design
Clinical trial with control group, parallel group trial, phase 3 on 220 patients. Replacement randomization was used.
Settings and conduct
This is a randomized controlled clinical trial study
conducted on 220 patients with Helicobacter Pylori infection referred to Imam Khomeini Hospital gasterointestinal clinic or attending office in Ahvaz. The patients were treated with one of two antibiotic regimens.The Eradication was determined by Stool antigen tests test at least 1 month after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria were as follows: chronic gastritis with or without healed duodenal or stomach ulcer
H. pylori positive determined by Rapid UreaseTest or Urea Breath Test
treatment-naive patients for eradication of H. pylori infection
Exclusion criteria: allergy to medications used in this clinical trial
use of PPI, histamine H2-receptor antagonists, antibiotics, bismuth, or probiotics 4 weeks before initiating study, pregnancy or breastfeeding
Intervention groups
Control group:Bismuth containing Quadruple thrapy{ clarithromycin 500 mg and amoxicillin 1 g and bismuth 220mg all twice per day), a proton pump inhibitor (pantoprazole 40 mg twice daily) all for 14 days}
Intervention group: amoxicillin 750mg QID and pantoprazole 40mg TDS for 14 days
Main outcome variables
Rate of eradication Helicobacter pylori ,Cost of treatment,Drugs side effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201007048956N1
Registration date:2020-11-09, 1399/08/19
Registration timing:retrospective
Last update:2020-11-09, 1399/08/19
Update count:0
Registration date
2020-11-09, 1399/08/19
Registrant information
Name
Amin Sabbaghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 0421
Email address
sabbaghanamin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-25, 1398/06/03
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
2019-09-11, 1398/06/20
Actual recruitment end date
2020-03-05, 1398/12/15
Trial completion date
2020-07-26, 1399/05/05
Scientific title
Eradication Efficacy of high dose amoxicillin and PPI Compared with standard bismuth containing quadruple Therapy as a First Line Treatment of Helicobacter pylori
Public title
Treatment of Helicobacter pylori infection of the stomach
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
chronic gastritis with or without healed duodenal or stomach ulcer
H. pylori positive determined by Rapid UreaseTest or Urea Breath Test
treatment-naive patients for eradication of H. pylori infection
Exclusion criteria:
allergy to medications used in this clinical trial
use of PPI, histamine H2-receptor antagonists, antibiotics, bismuth, or probiotics 4 weeks before initiating study
pregnancy or breastfeeding
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
220
Actual sample size reached:
194
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the Restricted randomization method of block randomization. Blockage is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where intermediate analyzes are required during the sampling process. All blocks are the same size, and in this two-group experiment we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group).
Random allocation software software is also used to randomize random sequence production software (Random allocation software).
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 ahwaz University of Medical Sciences
Street address
Ground floor central organization of Ahwaz Jundishapur University,Glestan Street.
City
Ahwaz
Province
Khouzestan
Postal code
6133944753
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.AJUMS.REC.1398.645
Health conditions studied
1
Description of health condition studied
helicobacter 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
helicobacter pylori infection
Timepoint
45 days after intervention
Method of measurement
stool antigen test of helicobacter pylori
Secondary outcomes
1
Description
Reduce the cost of treatment
Timepoint
45 days
Method of measurement
Lower cost
2
Description
Less drug side effects
Timepoint
45 days
Method of measurement
Patient clinical sign
Intervention groups
1
Description
Intervention group: amoxicillin 750mg QID and pantoprazole 40mg TDS for 14 days
Category
Treatment - Drugs
2
Description
Control group:Bismuth containing Quadruple thrapy{ clarithromycin 500 mg and amoxicillin 1 g and bismuth 220mg all twice per day), a proton pump inhibitor (pantoprazole 40 mg twice daily) all for 14 days}
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamkhomeini hospital
Full name of responsible person
Amin sabbaghan
Street address
24meter Ave.,Azadegan,Emamkhomeini hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 9367 3111
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadimoghadam
Street address
Ahwaz central medical sciences organization,golestan Ave.
City
ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Amin Sabbaghan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No.۲۸,soghrat Ave.,amaniye Town
City
Ahwaz
Province
Khouzestan
Postal code
6133944753
Phone
+98 61 3336 0421
Fax
Email
Sabbaghanamin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amin Sabbaghan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No.۲۸,soghrat Ave.,amaniye Town
City
Ahwaz
Province
Khouzestan
Postal code
6133944753
Phone
+98 61 3336 0421
Fax
Email
Sabbaghanamin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amin Sabbaghan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No.۲۸,soghrat Ave.,amaniye Town
City
Ahwaz
Province
Khouzestan
Postal code
6133944753
Phone
+98 61 3336 0421
Fax
Email
Sabbaghanamin@yahoo.com
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