A comparison between sequential therapy versus standard quadruple therapy for Helicobacter pylori eradication in patients attended to firoozgar and rasul hospitals
Due to the progressive decline in the usefulness of traditional diets, new approaches to treatment of H.pylori has been proposed. A promising approach is the sequential regimen (sequential).Side two treatment regimens. The main objectives of the project: the sequential regimen and standard four drug regimen will be compared in Helicobacter pylori eradication.Randomly divided into two groups of patients. For one of two groups of quadruple therapy and sequential therapy for other begins. 4 drug regimen consisting of omeprazole, amoxicillin, clarithromycin, is bismuth. Sequential regimen consisting of two stages. Step 1: 7 days of treatment with omeprazole + amoxicillin. Step 2: 7 days omeprazole + clarithromycin + Fvrazvlydn 8 weeks after treatment for eradication UBT test is called and then the two groups are compared. Exclusion criteria for the study of allergy to antibiotics. The total sample size of n = 160
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112288546N1
Registration date:2012-04-07, 1391/01/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-07, 1391/01/19
Registrant information
Name
Siamak Khaleghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1633
Email address
s-khaleghi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between sequential therapy versus standard quadruple therapy for Helicobacter pylori eradication in patients attended to firoozgar and rasul hospitals
Public title
Sequential regimens in the treatment of Helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria is confirming the diagnosis of H. pylori infection by RUT or histology. Exclusion criteria for this study is allergy to antibiotics.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Mdical Sciences Ethics Committee
Street address
class 5,tehran university building, ghods street,,keshavarz Boulevard,tehran
City
Tehran
Postal code
1417613151
Approval date
2011-08-24, 1390/06/02
Ethics committee reference number
867/130/د/90
Health conditions studied
1
Description of health condition studied
Indigestion
ICD-10 code
K30
ICD-10 code description
Dyspepsia
Primary outcomes
1
Description
Response to treatment
Timepoint
8 weeks after treatment.
Method of measurement
UBT test
Secondary outcomes
1
Description
Intensity and pattern of gastritis
Timepoint
Before treatment
Method of measurement
Observed on endoscopy
2
Description
Smoking
Timepoint
Baseline
Method of measurement
Pack /year, The question of the individual
3
Description
Body mass index
Timepoint
Baseline
Method of measurement
Kg/m2, With scales and meters
Intervention groups
1
Description
patients randomly divided into two groups . quadruple therapy for control group was began. 4 drug regimen consisting of omeprazole (20mg BID), amoxicillin 1gr BID)), clarithromycin (500mg BID), is bismuth.
Category
Treatment - Drugs
2
Description
sequential therapy forcase group was began.Sequential regimen consisting of two stages. Step 1: 7 days of treatment with omeprazole (20mg BID) + amoxicillin (1gr BID) is. Step 2: 7 days of omeprazole (20mg BID + Fvrazvlydn (100mg BID) + clarithromycin 500mg BID)) 8 weeks after treatment for eradication UBT test is called and then the two groups are compared
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool akram hospital
Full name of responsible person
Dr.Siamak khaleghi
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tehran University of medical sciences
Full name of responsible person
Ms. Malmir
Street address
Room 505,Floor 5,ghods st., Keshavarz Blvd, Tehran University of Medical Sciences, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tehran University of medical sciences