Protocol summary
-
Study aim
-
Determination of Helicobacter Remedy in the 4-Day Medicinal Product containing levofloxacin in patients with dyspepsia
-
Design
-
Clinical trials in the 4th drug regimen
-
Settings and conduct
-
Patients referred to the gastroenterology clinic and internal wards of the Shahid Beheshti Hospital of Kashan in the year 1339-98, who have been diagnosed with Helicobacter Pylori infection following gastroscopy and biopsy or fecal antigen test. It should be noted that the patients were given the necessary explanations regarding the observance of food safety and the correct and regular administration of medications. At the end of the first and second weeks of treatment, patients were registered for the correct use of drugs and adverse drug reactions, and all cases were recorded in the questionnaire. After the end of the antibiotic treatment period, treatment with omeprazole is continued for another 4 weeks and 4 weeks after discontinuation of omeprazole, a fecal antigen test is performed for both groups to confirm the eradication of the infection.
-
Participants/Inclusion and exclusion criteria
-
Patients referred to the gastroenterology clinic and internal wards of the Shahid Beheshti Hospital of Kashan in the year 1339-98, who have been diagnosed with Helicobacter Pylori infection following gastroscopy and biopsy or fecal antigen test.
-
Intervention groups
-
Eradication rate of Helicobacter in a 4-drug regimen containing levofloxacin in treated patients
Eradication rate of Helicobacter in Clarithromycin-containing drug regimen in patients undergoing treatment
The rate of eradication of Helicobacter in the 4-drug regimen of levofloxacin is different from that of Clarithromycin in dyspeptic patients.
The incidence of common adverse drug reactions in patients treated with levofloxacin
-
Main outcome variables
-
Eradication of Helicobacter with Medication
General information
-
Reason for update
-
A typo is incorrect in entering the sample size and in contrast to the experimental number
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20190606043826N1
Registration date:
2019-06-24, 1398/04/03
Registration timing:
retrospective
Last update:
2019-12-26, 1398/10/05
Update count:
1
-
Registration date
-
2019-06-24, 1398/04/03
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-06-05, 1398/03/15
-
Expected recruitment end date
-
2019-06-20, 1398/03/30
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Comparison of levofloxacin versus clarithromycin efficacy in bismuth-containing quadruple therapy for helicobacter pylori eradication
-
Public title
-
Comparison of levofloxacin versus clarithromycin efficacytherapy for helicobacter pylori eradication
-
Purpose
-
Prevention
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Positive h.pylori people have indications of treatment
Age between 14 and 70 years
Patients with informed consent to participate in the study
Exclusion criteria:
Do not use the correct and regular drug
Incidence of unbearable side effects
Pregnancy and lactation
The presence of chronic liver, kidney and gastrointestinal diseases simultaneously
Previous history of h.pylori treatment in a recent month
-
Age
-
From 14 years old to 70 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
194
-
Randomization (investigator's opinion)
-
N/A
-
Randomization description
-
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-05-27, 1397/03/06
-
Ethics committee reference number
-
IR.KAUMS.MEDNT.REC.1397.017
Health conditions studied
1
-
Description of health condition studied
-
Helicobacter pylori
-
ICD-10 code
-
B98.0
-
ICD-10 code description
-
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Primary outcomes
1
-
Description
-
The presence or absence of stool antigen,
-
Timepoint
-
At the end of the first and second weeks of treatment
-
Method of measurement
-
Fecal antigen test to confirm eradication of infection
2
-
Description
-
Incidence or absence of drug side effects
-
Timepoint
-
At the end of the first and second weeks of treatment
-
Method of measurement
-
questionnaire
Intervention groups
1
-
Description
-
The intervention group was as follows treated with 4 doses of bismuth substrate (2 tablets every 12 hours), omeprazole (20 mg every 12 hours),amoxicillin (1 g every 12 hours) Clarithromycin (500 mg every 12 hours)
-
Category
-
Treatment - Drugs
2
-
Description
-
The intervention group : treated with 4 drugs including bismuth subcetate (2 tablets every 6 hours), omeprazole (20 mg every 12 hours), amoxicillin (1 g every 12 hours) Levofloxacin (500 mg every 12 hours)
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Kashan 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
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
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Not applicable
-
Title and more details about the data/document
-
Part of the data relating to the Helicobacter counts can be shared.
-
When the data will become available and for how long
-
After analyzing the results, the data access period is free.
-
To whom data/document is available
-
Academic Institutions and Researchers
-
Under which criteria data/document could be used
-
For use in future studies.
-
From where data/document is obtainable
-
Corresponding Author
-
What processes are involved for a request to access data/document
-
Send an email to the author and get the information
-
Comments
-