Helicobacter pylori infection is the major cause of chronic gastritis ,peptic ulcer,gastric adenocarcinoma and gastric lymphoma(MALT).helicobacter eradication prevents recurrence of peptic ulcer and reduces the risk of gastric cancer.standard triple therapy is the first line for eradication of helicobacter pylori that is composed of a PPi or H2b with one or two antibiotic(clarythromycine,amoxicillin,metronidazole) For 7-14 days.but resistance to antibiotics reduces the efficacy of therapeutic regimen.resistance to clarythromycine is increasing worldwide,and is considered to be a primary factor reducing efficacy against h.pylori.
Several studies from iran was published that reported the resistance rate to clarithromycin is between 16-30/1%.
Some studies have shown excellent eradication rates(85-95%) with triple therapy based on levofloxacin as .levofluxacin is safe and telorated well by patient.so we decided to design a study to compare standard trple therapy based on clarithromycine with triple therapy based on levofloxacin in our area.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030421328N1
Registration date:2015-03-26, 1394/01/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-26, 1394/01/06
Registrant information
Name
Shahriyar Savadkoohi
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8284
Email address
sh.soleimani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor Of Research Babol University Of Medical Science
Expected recruitment start date
2014-10-22, 1393/07/30
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between levofluxain and clarithromycin treatment in helicobacter pylori eradication
Public title
Comparison between levofluxain and clarithromycin treatment in helicobacter pylori eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:complaint of dyspepsia
Exclusion criteria:using ppi or h2b during recent 4weeks,past history of gastric surgery,past history of gastric cancer,pregnancy,comorbid diseases.
Age
From 18 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University Of Medical Sciences
Street address
Daneshgah Sq - Ganjafrooz St-
City
Babol
Postal code
4717641367
Approval date
2014-03-08, 1392/12/17
Ethics committee reference number
3810 /30/ژ/پ
Health conditions studied
1
Description of health condition studied
Helicobacter pylori
ICD-10 code
K20-K31
ICD-10 code description
Diseases of oesophagus, stomach and duodenum
Primary outcomes
1
Description
eradication rate of helicobacter pylori
Timepoint
4 weeks after the end of the intervention
Method of measurement
Stool Ag
Secondary outcomes
1
Description
Eradication rate of HP in male and female
Timepoint
4 weeks after intervention
Method of measurement
Stool Ag
2
Description
Endoscopic findings
Timepoint
Before the intervention
Method of measurement
Endoscopic
Intervention groups
1
Description
First group:
Omeprazole 20 mg daily,
Clarithromycin 500 mg daily
Ampxicillin 1 gr BD
Category
Treatment - Drugs
2
Description
Second group: Omeprazole 20 mg daily,
levofluxacin 500 mg daily
Ampxicillin 1 gr BD
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ruhani Hospital
Full name of responsible person
Dr Shahriar savadkoohi
Street address
Department of Internal Medicine, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue Babol
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
Full name of responsible person
Ali Akbar Moghadamnia
Street address
Babol University of Medical Sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Narges sadeghi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
A. treasure Street, University Square, the Office of Internal
City
Babol
Postal code
Phone
+98 11 3223 8284
Fax
Email
internalmedbabol@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Javad Shokri Shirvani
Position
Professor of Gastroenterology
Other areas of specialty/work
Street address
Daneshgah Sq - Ganjafrooz St-Babol
City
Babol
Postal code
Phone
+98 11 3223 8284
Fax
Email
internalmedbabol@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Narges Sadeghi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
City
Babol
Postal code
Phone
+98 11 3223 8284
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)