Comparison of the Efficacy of Drug Regimen with High Dose and Standard Dose of Metronidazole on Helicobacter pylori Eradication
Design
In this Randomized, Single Blinded Parallel Group Clinical Trial Study, 170 Patients with Positive Helicobacter Pylori Stool Antigen Test are Randomly Divided into two Groups of 85 Patients and each Group are Treated with One of the A or B regimen with Variable Dose of Metronidazole for 14 Days.
Settings and conduct
170 Patients with Complaint of Dyspepesia and Positive Helicobacter pylori Stool antigen Test who will Refer to Tadbir's Polyclinic of Urmia, are Divided into Group A and B, by Simple Randomization Method by Using Random Allocation Software. each Group will Consist of 85 Patients. These Groups will Receive Quadruple Therapy Regimen for 2 weeks. For group A Standard dose of Metronidazole and for Group B High Dose Metronidazole will be Given. Then, 4 Weeks after the Termination of Treatment, Drugs Adverse Effects will be Asked and Helicobacter pylori Eradication will be Assessed by Stool Antigen Test.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Dyspeptic Patients Older than 18 Years who Have Positive Helicobacter pylori Stool Antigen Test.
Exclusion Criteria: Patients who Do not Refer after Receiving the Medications, Patients who Take the Medications for less than 10 Days, Pregnant or Breastfeeding Women, Patients with the History of Major Cardiac, Pulmonary, Renal or Hepatic Disease, History of Known Side Effects to the Medications of Therapeutic Regimen
Intervention groups
Groups A and B will Receive Quadruple Therapy Regimen for 14 Days composed of Omeprazole 20 mg, Bismuth Subcitrate 135 mg , Amoxicillin 1000mg (All Given BID) with Metronidazole 500mg BID in Group A and TDS in Group B.
Main outcome variables
Success Rate in Eradicating of Helicobacter pylori Infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211012052740N1
Registration date:2021-10-16, 1400/07/24
Registration timing:prospective
Last update:2021-10-16, 1400/07/24
Update count:0
Registration date
2021-10-16, 1400/07/24
Registrant information
Name
Hadi Mirabasvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3660 7369
Email address
abasvandh08@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Therapeutic Effects of Metronidazole in Variable Doses in Eradication of Helicobacterpylori in Dyspeptic Patients
Public title
Effect of Variable Doses of Metronidazole in Treatment of Helicobacterpylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dyspeptic Patients with Positive Helicobacterpylori Stool Antigen Test
Older than 18 Years Old Persons
Exclusion criteria:
No Referring After Taking the Medication
Taking Medications for Less than 10 Days
Pregnant or Breastfeeding Women
Patients with the History of Major Cardiac, Pulmonary, Renal or Hepatic Disease
History of Known Side Effects to the Medications of Therapeutic Regimen
Taking Antibiotic during the Last Month
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is Done in Simple Method And Patients are Divided into Control and Intervention Groups in a List of Codes Prepared by Random Allocation Software.The Subjects are Assigned into Different Groups by Random Allocation. Allocation Concealment is Obtained by Maintaining the Randomization List by Study Statistician.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients Participating in the Study are not be Informed about the Type of their Treatment Regimen
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Urjans Alley, resalat Ave., Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-08-15, 1400/05/24
Ethics committee reference number
IR.UMSU.REC.1400.175
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
Eradication of Helicobacter pylori Infection
Timepoint
Four Weeks after the Termination of Treatment
Method of measurement
Helicobacter pylori Stool Antigen Test
Secondary outcomes
1
Description
Drug Adverse Effects Including: Nausa, Abdominal Pain, Metallic Taste, Diarrhea
Timepoint
Four Weeks after Starting the Treatment
Method of measurement
Questionnaire
2
Description
The Tolerance to Accepting the Treatment (Taking Medications more than 10 Days)
Timepoint
Two Weeks after Starting the Treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Group B Receives Following Medications for 14 Days: Tab Metronidazole 500 mg TDS, Omeprazole 20 mg BID, Amoxicillin 1000 mg BID, Bismuth Subcitrate 135 mg BID
Category
Treatment - Drugs
2
Description
Control group: Group A Receives Following Medications for 14 Days: Tab Metronidazole 500 mg BID, Omeprazole 20 mg BID, Amoxicillin 1000 mg BID, Bismuth Subcitrate 135 mg BID
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tadbir's Polyclinic
Full name of responsible person
mohammadreza mohammad hoseiny azar
Street address
Amar Ave., Tadbir's Polyclinic
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 2420
Email
diglib@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Urjans Alley, resalat Ave., Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
diglib@umsu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Mohammadreza Mohammad Hoseiny Azar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Amar Ave., Tadbir's Clinic
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 2420
Email
mohammadazar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammadreza Mohammad Hoseiny Azar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Amar Ave., Tadbir's Clinic
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 2420
Email
mohammadazar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammadreza Mohammad Hoseiny Azar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Amar Ave., Tadbir's Clinic
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 2420
Email
mohammadazar@gmail.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