Aim: Success rates of 10-day sequential therapies of gastric Helicobacter pylori infection will compare with 14-day standard therapy of that.
Methods and materials: through a longitudinal clinical trial, about 200 patients with helicobacter pylori gastritis or peptic ulcer for treatment divided in two groups of control and trial. The trial group treated with sequential regime and control group treated with standard regime of helicobacter pylori treatment. Four weeks after finishing of treatment patients should undergo urease breathing test and after that all data should be analyzed and written.
Inclusion criteria: All patients admitted to the infectious diseases clinics in Firuzgar hospital older than seventeen years; in presence of H. pylori gastritis or peptic ulcer that establish by specimens obtained by endoscopy and rapid urease test.
Exclusion criteria: The patients had not to be pregnant or lactating women, having chronic illness, such as cancer ( Especially gastrointestinal cancer ) , liver and kidney failure, positive history of antibiotic use in the two weeks prior to admission and no history of allergy to the antibiotics of our study.
Interventions: Trail group is treated with pantaprazole once a day for five days and amoxicillin 1 g twice a day and next 5 days they treated with the same dose of pantaprazole and levofloxacin 500 mg daily and tinidazole 500 mg twice a day and control group treated 14 days with pantaprazole 40 mg daily, clarithromycin 500 mg twice a day, amoxicillin 1 g twice a day and metronidazole 500 mg twice a day.
Main goal variable: Positive or negative results of urease breath test
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042817474N1
Registration date:2015-02-28, 1393/12/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-28, 1393/12/09
Registrant information
Name
Marzieh Daneshbodi
Name of organization / entity
Iran University of Medical Sciense
Country
Iran (Islamic Republic of)
Phone
+98 21 5539 1213
Email address
marziehdaneshbodi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor research of Iran university of medical science
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of treatment success rates in 10-day sequential therapies compare with 14-day standard therapy for Helicobacter pylori
Public title
Evaluation of treatment success rates in 10-day sequential therapies compare with 14-day standard therapy for Helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients over seventeen years, admitted to the infectious diseases clinics in Firoozgar hospital; the presence of H. pylori in the presence of gastritis or peptic ulcer specimens obtained by endoscopy and rapid urease test.
Exclusion criteria: pregnant or lactating women; having chronic illness, such as cancer ( Especially gastrointestinal cancer ) , liver and kidney failure; positive history of antibiotic use in the two weeks prior to admission; no history of allergy to the antibiotics studied.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
no registration
Secondary trial Id
no registration
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical ethic commitee of Iran University of Medical Sciense
Street address
Hemmat High Way,Cross Chamran Highway
City
Tehran
Postal code
Approval date
2014-07-06, 1393/04/15
Ethics committee reference number
93/5/105/1682
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
Urease Breath Test
Timepoint
one month after finishing of treatment
Method of measurement
The presence of H. pylori in the stomach by using carbon 13-labeled urea fed to the patient and the patient's breathing carbon measurement
Secondary outcomes
empty
Intervention groups
1
Description
Trial group treated with pantaprazole once a day for five days and amoxicillin 1 g twice a day and next 5 days they treated with the same dose of pantaprazole and levofloxacin 500 mg daily and tinidazole 500 mg twice the days.
Category
Treatment - Drugs
2
Description
group II (control) treated with pantaprazole 40 mg daily, clarithromycin 500 mg twice a day and amoxicillin 1 g twice a day and metronidazole 500 mg twice a day for 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firuzgar hospital
Full name of responsible person
Dr.Marzieh Daneshbodi
Street address
Valiasr squere, Valadi street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Iran University of Medical Sciences
Full name of responsible person
Dr Mousavi
Street address
Library of medical univercity, Hematt Highway cross ChamranHighway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Iran University of Medical Sciences
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
Medical university of Iran university
Full name of responsible person
Marzieh Daneshbodi
Position
Doctorate/ Internal medicine resident
Other areas of specialty/work
Street address
No 34, Gaberzade alley, Mokhtari street, Valiasr street
City
Tehran
Postal code
Phone
+98 21 5547 2157
Fax
Email
marziehdaneshbodi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran university of medical science
Full name of responsible person
Dr.Mitra Ranjbar
Position
specialist
Other areas of specialty/work
Street address
No34, Jaberzade alley, Mokhtari street, Valiasr street
City
Tehran
Postal code
Phone
+98 21 5547 2157
Fax
Email
Ranjbar.m@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran university of medical science
Full name of responsible person
Dr.Marzieh Daneshbodi
Position
Internal medicine resident
Other areas of specialty/work
Street address
No 12, Safa alley, Mokhtari street, Valiasr street
City
Tehran
Postal code
Phone
+98 21 5539 1213
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)