Objectives: The purpose of this study is to compare success rate of H.pylori eradication between 3 antibiotic regimes.
Major inclusion criteria and exclusion criteria: Patients with dyspepsia and Peptic ulcer disease were included. Patients with history of taking antibiotic in last 3 weeks, gastrointestinal bleeding, gastric cancer and taking PPI or H2 receptor antagonists in the last two week were excluded.
Design: This study will be conducted on 90 patients who referred to Gastroenterology Clinic in Qazvin province. Setting and conduct: Following the confirmation of H.pylori with Rapid urease test and randomization (balanced block randomization) they will be divided to 3 groups which each group will receive one of the following three regimens for a two-week period:
Intervention: First group: Tab Pantoprazole 40 mg bd /Cap Amoxicillin 1000 mg bd / Tab Clarithromycin 500 mg bd. Second group: Pantoprazole 40 mg bd/Cap Amoxicillin 1000 mg bd/Tab Levofloxacin 500 mg daily. Third group: Tab Pantoprazole 40 mg bd/Cap Amoxicillin 1000 mg bd /Tab Furazolidone 100 mg bd. Main outcome variables: Three weeks after the termination of treatment, H. pylori stool antigen test will be checked for all patients to confirm eradication of H. pylori.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040318124N4
Registration date:2017-10-07, 1396/07/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-07, 1396/07/15
Registrant information
Name
Ali Akbar Hajiaghamohammadi
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3336 0084
Email address
ahmohammadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing success rate of three antibiotic regimes based on furazolidone, clarithromycine and levofluxacin in patients with Helicobacter pylori
Public title
Comparing success rate of three antibiotic regimes based on furazolidone, clarithromycine and levofluxacin in patients with gastric infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 15 to 80 years; patients with dyspepsia and Peptic ulcer disease; Patients undergoing upper endoscopic procedure with positive rapid urease test (RUT).
Exclusion criteria: gastrointestinal bleeding; Patients with history of taking antibiotic in last 3 weeks; taking PPI or H2 receptor antagonists in the last two week; gastric cancer; suffering from any disease needing to consume another antibiotic
Age
From 15 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
balanced block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Qazvin University of Medical Sciences
Street address
Qazvin, Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2017-04-08, 1396/01/19
Ethics committee reference number
IR.QUMS.REC.1396.62
Health conditions studied
1
Description of health condition studied
Helicobacter pylori
ICD-10 code
B98
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters