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Comparing the five-drug regimen ( Bismuth sub-citrate , Omeprazole , Amoxicillin , Clarithromycin , Tinidazole ) and ( Bismuth sub citrate , Omeprazole , Tetracycline , Metronidazole , Ofloxacin ) on the eradication rate of Helicobacter pylori infection in non responder dyspeptic patients

Protocol summary

Summary
This study compared two five-drug regiment , Protocol I ( Bismuth sub citrate , Omeprazole , Amoxicillin , Clarithromycin , Tinidazole ) and Protocol II (Bismuth sub citrate , Omeprazole , Tetracycline , Metronidazole and Ofloxacin ) on the eradication rate of Helicobacter pylori infection in dyspeptic patients resistant to treatment. The sample census will be the method in this way all patients referred to digestive clinics in Rasht that under drug treatment and resistant to quadriple or triple regiment and did not show a positive response during a year are enrolled. Helicobacter pylori positive patients over 15 years and less than 65 years that under regiment triple or quadruple drugs and urea breath test (UBT) using carbon 14 ( C14 or C13 or stoolAg ) with the European protocol were positive again , enter are studied. The patients are divided into two categories : The first group under five drug regiment ( Bismuth sub citrate 240 milligram two time in day , Omeprazole 20 milligram two time in day, Amoxicillin 1 gram two time in day, Clarithromycin 500 milligram two time in day , Tinidazole 500 milligram two time in day and the second group treated with Bismuth sub-citrate 240 milligram two time in day , Omeprazole 20 milligram two time in day , Tetracycline 500 milligram two time in day , Metronidazole 500 milligram two time in day , Ofloxacin 200 milligram two time in day ) for a week. Then , after the end of 12 weeks of treatment to evaluate treatment with C13 UBT and stool antigen ( stool Ag ) Eradication will be used and if the negative will be considered. If any of the positive tests of helicobacter pylori positive patients considered to be. Also on the end of a week after treatment of drug side effects and the amount of drug use by patients examined.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201103011155N11
Registration date: 2011-07-03, 1390/04/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-07-03, 1390/04/12
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
vice chancellor for research Guilan university of medical sciences
Expected recruitment start date
2011-02-09, 1389/11/20
Expected recruitment end date
2012-02-09, 1390/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the five-drug regimen ( Bismuth sub-citrate , Omeprazole , Amoxicillin , Clarithromycin , Tinidazole ) and ( Bismuth sub citrate , Omeprazole , Tetracycline , Metronidazole , Ofloxacin ) on the eradication rate of Helicobacter pylori infection in non responder dyspeptic patients
Public title
Comparing regimens ( Bismuth sub-citrate , Omeprazole , Amoxicillin , Clarithromycin , Tinidazole ) and ( Bismuth sub citrate , Omeprazole , Tetracycline , Metronidazole , Ofloxacin ) on the eradication rate of Helicobacter pylori infection in non responder dyspeptic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: In this study , helicobacter pylori positive patients over 15 years and less than 65 years that under drug treatment regiment quadriple or triple placed urea breath test (UBT) using carbon 14 (C14 or C13 or stoolAg) with the European protocol again have been positive , will enter the study. Exclusion : Pregnant women , Patients with gastric malignancy , Cirrhosis , Patients with allergy to Amoxicillin or Clarithromycin , Omeprazole , Tetracycline , Ofloxacin , Metronidazole and Tinidazole , Colestramin Consumption , Renal failure , History of seizures , Blood disorders , Fauvism and treatment of patients with incomplete (less than 80%) will be excluded.
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences. Ethics Committee Gastrointestinal and Liver Diseases Research
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht
Postal code
955655-41488
Approval date
2011-03-03, 1389/12/12
Ethics committee reference number
ش/160

Health conditions studied

1

Description of health condition studied
dyspepsia
ICD-10 code
k30
ICD-10 code description
Dyspepsia

Primary outcomes

1

Description
Helicobacter pylori eradication
Timepoint
12 week
Method of measurement
ureas breath test with c14 and stool antigen

Secondary outcomes

empty

Intervention groups

1

Description
The first group treated with diet five drug protocol I ( Bismuth sub citrate 240 miligeram two time in day Construction Company Kimdaru drug 120 miligeram of two every 12 hours is given , Omeprazole 20 miligeram two time in day Construction Company doctor abidi capsule 20 miligeram every 12 hours of a number , Amoxicillin 1 geram two time in day Construction Co , two 500 mg capsules every 12 hours , Clarithromycin 500 miligeram two time in day Abbott Construction Company a number every 12 hours , making pars Tinidazole 500 miligeram two time in day drug every 12 hours that a number of drug to be prescribed for a week.
Category
Treatment - Drugs

2

Description
Another group treated with protocol II (Bismuth sub citrate 240 miligeram two time in day Construction Co Kimydaru one number per 12 hours , Omeprazole 20 miligeram two time in day Construction Company doctor abidi a number every 12 hours , Tetracycline 500 miligeram two time in day Construction Company Razak two every 12 hours , Metronidazole 500 miligeram two time in day Construction Company Alborz number every 12 hours , Ofloxacin 200 miligeram two time in day Construction Co. exir number every 12 hours a week will be given.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr. Fariborz Mansour ghanei
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vince chancellor for reaserch guilan univercity of medical sciences
Full name of responsible person
Sadati st, Samjoo st, Rasht,Guilan
Street address
Dr Rasool Tabari KHomeirani
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vince chancellor for reaserch guilan univercity 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
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Farahnaz Joukar
Position
Gastrointestinal and Liver Diseases Research Center
Other areas of specialty/work
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi hospital, Rasht
City
Rasht
Postal code
955655-41448
Phone
+98 13 1553 5116
Fax
Email
info@gldrc.org
Web page address
www.gldrc.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr.Fariborz Mansour-Ghanei
Position
Full Professor of Internal Medicine & Gastroenterology
Other areas of specialty/work
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht
Postal code
95655-41448
Phone
+98 13 1553 5116
Fax
Email
info@gldrc.org
Web page address
www.gldrc.org

Person responsible for updating data

Contact
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr Arezoo Fani
Position
Doctor/ Researcher
Other areas of specialty/work
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht
Postal code
95655-41448
Phone
+98 13 1553 5116
Fax
Email
info@gldrc.org
Web page address
www.gldrc.org

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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