: Comparison of the effect of OABM WITH OABF regimens in In the treatment of Helicobacter pylori patients referred to Mofateh Clinic1 of Yasuj University of Medical Sciences in 2022-2023
Design
Phase 3 clinical trial in two parallel groups receiving the regimen ABF(omeprazolo_furazolidone_bismuth subcitrate_ amoxicillin) and OABM(omeprazolo_metronidazole_bismuth subcitrate _amoxicillin), single blind, randomized using a table of numbers
Settings and conduct
This study will be conducted in the field of Helicobacter pylori infection treatment in Yasouj University of Medical Sciences in Fatah 1 Clinic. The study is performed on patients with personal consent. Patients will receive ABF or OABM drug in two groups randomly. The researchers were blinded to the type of intervention assigned to the patients.
Participants/Inclusion and exclusion criteria
Patients with dyspepsia, without indication for endoscopy, with a positive Helicobacter diagnostic test, including Helicobacter stool antigen test
Intervention groups
In one group, omeprazole 20 mg twice a day (Bid) is continued for two weeks with antibiotics and then for 6 weeks without antibiotics, and after 4 weeks of this treatment period, the patient gives a stool antigen test to check the eradication of Helicobacter pylori. Amoxicillin 1 gram twice a day, bismuth citrate tablets twice a day and furazolidone 200 mg twice a day (Bid), in the other group omeprazole 20 mg twice a day along with antibiotics for 2 weeks and then for 6 weeks without antibiotics and alone and after this 6-week period, the patient will refer to stool antigen test method 4 weeks later without taking drugs and antibiotics for eradication test. In this group, amoxicillin one gram twice in day and two tablets of bismuth citrate twice a day (4 tablets a day) and metronidazole 500 mg twice a day
Main outcome variables
Helicobacter pylori antigen negativity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150622022869N11
Registration date:2023-06-11, 1402/03/21
Registration timing:prospective
Last update:2023-06-11, 1402/03/21
Update count:0
Registration date
2023-06-11, 1402/03/21
Registrant information
Name
Moslem Sedaghattalab
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0163
Email address
m.sedaghattalab@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-07-01, 1402/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of OABM WITH OABF regimens in In the treatment of Helicobacter pylori patients
Public title
Comparison of the effect of OABM WITH OABF regimens in In the treatment of Helicobacter pylori patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient who underwent endoscopy and has peptic ulcer disease (PUD).
Patients with dyspepsia without endoscopic indication have a positive Helicobacter diagnostic test, including Helicobacter stool antigen test and....
Patients with maltoma
Endoscopy patients with nud (non-ulcer dyspepsia) and patients with a history of cancer in their first degree relatives will be included in the study.
Patients who have a history of pud and are Helicobacter positive and are taking NSAID
Treatment-resistant dyspepsia
Patient satisfaction
Exclusion criteria:
Previous history of H pylori treatment
Allergy to antibiotics
Allergy to PPI
History of gastrectomy
Having gastric cancer
pregnant women
Taking antibiotics in the last month
Taking PPI or h2blocker in the last two weeks
Chronic liver, kidney or lung disease
History of Fauvism
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table method is used for randomization in this study. In this method, random table is used for randomization and patients are assigned random numbers from the table. Patients in each of the two study groups will be assigned to one of the two groups based on random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study will be single blind, in which the researchers of this study will be blinded to the type of intervention assigned to the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofYasuj University of Medical Sciences
Street address
Dr. Jalil St., campus of Yasouj University of Medical Sciences., Yasuj., Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Approval date
2023-01-03, 1401/10/13
Ethics committee reference number
IR.YUMS.REC.1401.159
Health conditions studied
1
Description of health condition studied
helicobacter pylori (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
Frequency distribution of Helicobacter pylori antigen negativity
Timepoint
12weeks after the start of the study
Method of measurement
Stool antigen test
2
Description
Drug side effects
Timepoint
12 weeks
Method of measurement
Clinical examination and patient presentation
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: omeprazole 20 mg twice a day (Bid) is continued for two weeks with antibiotics and then for 6 weeks without antibiotics, and after 4 weeks of this treatment period, the patient gives a stool antigen test to check the eradication of Helicobacter pylori. Amoxicillin 1 gram twice a day, bismuth citrate tablets twice a day and furazolidone 200 mg twice a day (Bid)
Category
Treatment - Drugs
2
Description
Second intervention group: omeprazole 20 mg twice a day along with antibiotics for 2 weeks and then for 6 weeks without antibiotics and alone and after this 6-week period, the patient will refer to stool antigen test method 4 weeks later without taking drugs and antibiotics for eradication test. In this group, amoxicillin one gram twice in day and two tablets of bismuth citrate twice a day (4 tablets a day) and metronidazole 500 mg twice a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Muftah Clinic
Full name of responsible person
Moslem Sedaghattalab
Street address
Dr. Jalil St., campus of Yasouj University of Medical Sciences., Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 5876
Email
m.sedaghattalab@yums.ac.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlagh
Street address
Dr. Jalil St., campus of Yasouj University of Medical Sciences,. Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 5876
Email
aminhomo@yahoo.com
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
Moslem Sedaghttalab
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Dr. Jalil St., campus of Yasouj University of Medical Sciences,. Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 5876
Email
m.sedaghattalab@yuma.ac.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghttalab
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Dr. Jalil St., campus of Yasouj University of Medical Sciences,. Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 5876
Email
m.sedaghattalab@yuma.ac.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Sedaghttalab
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Dr. Jalil St., campus of Yasouj University of Medical Sciences,. Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 5876
Email
m.sedaghattalab@yuma.ac.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data of this study can be shared without mentioning individuals and in aggregate form after the publication of the article through administrative correspondence.
When the data will become available and for how long
After printing the article
To whom data/document is available
this is available for people working in academic institutions or people working in businesses can also apply to receive it.
Under which criteria data/document could be used
Any analysis on the data will be allowed
From where data/document is obtainable
m.sedaghattalab@yuma.ac.com
What processes are involved for a request to access data/document
After sending the email, the required data will be available for up to 1 month