Investigating the local antibiotic resistance of Helicobacter pylori to provide physicians with more informed drug choices for better treatment of Helicobacter infection.
Design
Clinical trial with parallel groups, randomized to two treatment groups (Random allocation), phase 2 on 334 patients.
Settings and conduct
At first, a written personal consent will be obtained from all patients referring to Mufteh Yasouj clinic. Patients will be between 15 and 80 years old.
Confirmation of H. pylori diagnosis in all the people investigated in this study will be done by stool antigen test. Patients who are confirmed to have H. pylori diagnosis will be randomly and automatically in one of the two treatment groups of four eradication drugs. H pylori based on levofloxacin (group A) or metronidazole (group B) will be 1.1.
Blinding was not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients with peptic ulcer
2. Mallet's lymphoma
3. Atrophic gastritis
4. Intestinal metaplasia
5. First degree people with stomach cancer
6. Treatment-resistant dyspepsia
Exclusion criteria :
1. Previous history of H pylori treatment
2. History of gastrectomy
3. Having gastric cancer
4. Pregnant women
5. Use of antibiotics in the last one month, PPI or h2blocker use in the last two weeks
6. Chronic liver, kidney or lung disease.
Intervention groups
The intervention group includes patients with dyspepsia who are indicated for Helicobacter pylori treatment and receive intervention A.
The comparison group includes patients with dyspepsia who are indicated for Helicobacter pylori treatment and receive intervention B.
Main outcome variables
Investigating the local antibiotic resistance of Helicobacter pylori; More informed drug choices for doctors to better treat Helicobacter infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240803062624N1
Registration date:2024-10-03, 1403/07/12
Registration timing:retrospective
Last update:2024-10-03, 1403/07/12
Update count:0
Registration date
2024-10-03, 1403/07/12
Registrant information
Name
Ladan Delgarm
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 8515
Email address
ladan.delgarm@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-01-30, 1402/11/10
Actual recruitment start date
2023-09-03, 1402/06/12
Actual recruitment end date
2024-03-05, 1402/12/15
Trial completion date
empty
Scientific title
Comparative study of the effect of levofloxacin with metronidazole in the 4-drug eradication regimen of Helicobacter pylori
Public title
"Effect of metronidazol in treatment of hpylori""Effect of levofloxacin in treatment of hpylori"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to Shahid Muftah Yasouj clinic with symptoms of dyspepsia, whose H. pylori infection was confirmed by stole antigen test and indicated for H. pylori eradication
Patients with peptic ulcer
Malt lymphoma
Atrophic gastritis
Intestinal metaplasia
First degree people with stomach cancer
Treatment-resistant dyspepsia
Exclusion criteria:
Previous history of H pylori treatment
History of gastrectomy
Having gastric cancer
Pregnant women
Use of antibiotics in the last one month, use of ppi or h2blocker in the last two weeks
Chronic liver, kidney or lung disease
Age
From 15 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
334
Actual sample size reached:
321
Randomization (investigator's opinion)
Randomized
Randomization description
First, we put the number of participants (167 A cards and 167 B cards) in a dark box, then the selection is made by randomly drawing a card from the box.
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 Yasuj University of Medical Sciences
Street address
Yasuj, Shahid Motahari Blvd., Yasouj University of Medical Sciences, Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2023-10-11, 1402/07/19
Ethics committee reference number
IR.YUMS.REC.1402.115
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 stool antigen
Timepoint
First study and 4 weeks after treatment
Method of measurement
Helicobacter pylori stool antigen test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: In this group, omeprazole 20 mg twice a day (bid) for two weeks along with an antibiotic regimen (amoxicillin 1 gram twice a day (56 tablets during the treatment period) and two bismuth citrate tablets twice daily and levofloxacin 500 mg daily) and then continue to take omeprazole for 6 weeks without antibiotics and alone, and after this 6-week period, the patient 4 weeks later without taking drugs and antibiotics for the root test Kenny refers to the stool antigen test method.The drugs used in the study are from the pharmaceutical companies of Farabi and Obeidi.
Category
Treatment - Drugs
2
Description
Intervention group B: In this group, omeprazole 20 mg twice a day along with antibiotic regimen (amoxicillin 1 gram twice a day and two bismuth citrate tablets twice a day and metronidazole 500 mg twice a day) were given for two weeks. and then continue taking omeprazole for 6 weeks without antibiotics and alone, and after this 6-week period, the patient will refer to stole antigen test method 4 weeks later without taking drugs and antibiotics.The drugs used in the study are from the pharmaceutical companies of Farabi and Obeidi.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh clinic
Full name of responsible person
Bahram Mohammadi
Street address
Golestan Alley 15 ,Pasdaran St.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7135646196
Phone
+98 74 9101 3813
Email
info@yasuj.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amin Hosseini
Street address
Golestan Alley 15.,Pasdaran St
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7135646196
Phone
+98 74 3333 7230
Email
info@yasuj.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Ladan Delgarm
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 2 , 6th Alley , Khayyam St ., Shiraz City
City
Shiraz
Province
Fars
Postal code
7135646196
Phone
+98 71 3230 8515
Fax
Email
Ladan.delgarm@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ladan Delgarm
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 2 , 6th Alley , Khayyam St ., Shiraz City
City
Shiraz
Province
Fars
Postal code
7135646196
Phone
+98 71 3230 8515
Fax
Email
Ladan.delgarm@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ladan Delgarm
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 2 , 6th Alley , Khayyam St ., Shiraz City
City
Shiraz
Province
Fars
Postal code
7135646196
Phone
+98 71 3230 8515
Fax
Email
Ladan.delgarm@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