The Efficacy of Metronidazole , Amoxicilin, Bismuth, Omeprazole – (OMAB) Based Quadruple Therapy for Eradication of Helicobacter Pylori Infection in Hamedanian Patients
Helicobacter pylori has strong association with peptic ulcer in patients with peptic ulcer. It is recommended to eradicate the germ. Various treatment regimes exist with different efficacy and side effects. Choosing treatment regime depends on effectiveness, tolerance, resistance to antibiotics and drug price. The aim of treatment is eradication of infection in 85-90% of cases. Resistance to antibiotic is the most common cause of failure in treatment in patients with full participation. Occurrence rate and resistant species to antibiotics is different in various parts of the world. The most effective treatment regime in Iranian’s literature is herbal medications based on claritromycine or furazoulidon but because of side effects of Furazoulidon and high cost of claritromycine, most physicians prescribe Metronidazole, Amoxi ciline, Bismout and Omeprazol (OMAB regime). Due to drug resistance in different parts, this study is necessary to determine effectiveness of drug regime. Patients referring to Shahid Beheshti hospital of Hamadan with peptic ulcer symptoms undergo Endoscopy. In the case of any lesion due to Helicobacter, sample was taken by biopsy and after confirming germ by pathologist, patients treated whit four drugs including 2omg omeprazol , 1000mg Amoxiciline, 240mg Bismute and 500mg Metronidazole twice daily for two weeks. Then they treated with omeprazole for 4 weeks. After 3 months of treatment urea Breath test (UBT) will be done by labeled carbon. If the test was negative, eradication is successful. Obtained samples in 1 year will be reported and results will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901213676N1
Registration date:2010-05-11, 1389/02/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-11, 1389/02/21
Registrant information
Name
Mohammad Reza Tavakoli
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 6295
Email address
mr.tavakoli@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research committee of Hamedan University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Metronidazole , Amoxicilin, Bismuth, Omeprazole – (OMAB) Based Quadruple Therapy for Eradication of Helicobacter Pylori Infection in Hamedanian Patients
Public title
The Efficacy of Metronidazole , Amoxicilin, Bismuth, Omeprazole – (OMAB) Based Quadruple Therapy for Eradication of Helicobacter Pylori Infection in Hamedanian Patients
Purpose
Treatment
Inclusion/Exclusion criteria
All patients with peptic ulcer symptoms who need Endoscopy based on history an physical exam entered into this study. Exclusion criteria: antibiotic consumption in recent month; proton pump inhibitory drug or Bismut in recent 2 weeks or bleeding or any contradiction to endoscopy. In case of existing tumour in Endoscopy and not completing treatment, patients were also excluded
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan university of medical sciences
Street address
Mahdieh street
City
Hamedan
Postal code
00986517838736
Approval date
2010-02-25, 1388/12/06
Ethics committee reference number
175857/9/35/16/پ- 1-3-5-6-8-10-11
Health conditions studied
1
Description of health condition studied
Peptic ulcer disease
ICD-10 code
K27.9, K26
ICD-10 code description
Peptic ulcer, Deudenal ulcer, Gastritis
Primary outcomes
1
Description
ٍHelicobacter pylori infection
Timepoint
6 weeks after treatment
Method of measurement
Urea breathing test
Secondary outcomes
empty
Intervention groups
1
Description
OMAB Regime, Omeprazole20mg- metronidazole 500mg-amoxicillin1000mg-bismuth240mgtwice daily for2weeks then omeprazole20mg for 4weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
SHAHID BEHESHTI HOSPITAL
Full name of responsible person
Dr Mohammad Reza Tavakoli
Street address
ERAM STREET
City
HAMEDAN
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan university of medical sciences
Full name of responsible person
Dr Ali Reza Khalilian
Street address
Mahdieh street
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan university of medical sciences
Full name of responsible person
Dr Mohammad Reza Tavakoli
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Shahid Beheshti Hospital
City
Hamedan
Postal code
00986517953371
Phone
+98 81 1838 0286
Fax
+98 81 1838 0098
Email
mr.tavakoli@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Reza Khalilian
Position
Faculty member
Other areas of specialty/work
Street address
Shahid Beheshti Hospital
City
Hamedan
Postal code
00986517953371
Phone
+98 81 1838 0286
Fax
+98 81 1838 0098
Email
ar.khalilian@Gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan university of medical sciences
Full name of responsible person
Dr Mohammad Reza Tavakoli
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Shahid Beheshti Hospital
City
Hamedan
Postal code
00986517953371
Phone
+98 81 1838 0286
Fax
+98 81 1838 0098
Email
mr.tavakoli@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)