Aim: to study the effect of Sequential treatment regimen on H. pylori eradication in chronic renal failure and non-uremic patients. Sample size is 80. Inclusion criteria: patients with dyspepsia symptoms over the past one month from gastroenterology or nephrology clinic or hospital dialysis ward who have infection with H. Pylori confirmed by rapid urease test and biopsy in endoscopy. Exclusion Criteria : taking antibiotic regimen to eradicate H. pyloriand or receiving proton pump inhibitors, Bismuth, or NSAID during the last month; concomitant anticoagulant, corticosteroid or Ketoconazole; history of gastric or esophageal surgery; sensitivity to antibiotics; negative endoscopic biopsy; drinking alcohol and smoking; pregnancy and lactation; severe heart disease; diseases of the thyroid gland. The primary outcome: eradication of Helicobacter pylori infection. Interventions: Pantoprazul (BD40mg) and Amoxicillin (if keratinize clearance is between 10-30: 250-500mg BD and if it is less than 10: 250-500 mg Daily) for 5 days and then Pantoprazul (40mg BD) and clarithromycin (250 mg BD) and tinidazole (500mg BD) for 5 days. Control Group: Pantoprazul (40mg BD) and Claritromicine (250 mg BD)and Amoxicillin (if Kratinize cearance is between 10-30: 250-500mg BD and if it is less than 10: 250-500 mg Daily)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201231241N3
Registration date:2012-03-01, 1390/12/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-01, 1390/12/11
Registrant information
Name
Atieh Makhlough
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 4047
Email address
dr.makhloogh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2010-09-11, 1389/06/20
Expected recruitment end date
2011-07-11, 1390/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sequential therapy for eradication of H. Pylori infection in renal failure patients
Public title
Comparison of Sequential therapy for eradication of H. Pylori infection in renal failure patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with dyspepsia symptoms over the past one month from gastroenterology or nephrology clinic or hospital dialysis ward who have infection with H. Pylori confirmed by rapid urease test and biopsy in endoscopy. Exclusion Criteria : taking antibiotic regimen to eradicate H. pyloriand or receiving proton pump inhibitors, Bismuth, or NSAID during the last month; concomitant anticoagulant, corticosteroid or Ketoconazole; history of gastric or esophageal surgery; sensitivity to antibiotics; negative endoscopic biopsy; drinking alcohol and smoking; pregnancy and lactation; severe heart disease; diseases of the thyroid gland or liver cancer; chronic renal failure patients who are prior to stage 5 or have not received renal replacement therapy.
Age
From 20 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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
Mazandaran University of Medical Sciences
Street address
Building No. 2 of University, Moallem Square
City
Sari
Postal code
Approval date
2012-01-08, 1390/10/18
Ethics committee reference number
88-5
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori
Primary outcomes
1
Description
Eradication of Helicobacter pylori Infection
Timepoint
At the end of four weeks after treatment
Method of measurement
Urea Test
2
Description
Eradication of Helicobacter pylori Infection
Timepoint
At the end of four weeks after treatment
Method of measurement
Creatinine Clearance Test
3
Description
Eradication of Helicobacter pylori Infection
Timepoint
At the end of four weeks after treatment
Method of measurement
Stool examination
4
Description
Eradication of Helicobacter pylori Infection
Timepoint
At the end of four weeks after treatment
Method of measurement
Biopsy by Endoscopic
Secondary outcomes
1
Description
Acute Renal Failure
Timepoint
At the first and second weeks of treatment
Method of measurement
Testing Urea
2
Description
Acute Renal Failure
Timepoint
At the first and second weeks of Treatment
Method of measurement
creatinine clearance test
3
Description
Acute Renal Failure
Timepoint
at the first and second weeks of treatment
Method of measurement
weight
Intervention groups
1
Description
Intervention Group:Pantoprazul (BD40mg) and amoxicillin (If keratinize clearance is between 10-30:250-500mg BD and if it is less than 10:250-500 mg Daily)for 5 days and Then Pantoprazul (40mg BD) and clarithromycin (250 mg BD) and tinidazole (500mg BD) for 5 days
Category
Treatment - Drugs
2
Description
Control Group : Pantoprazul (40mg BD) and Claritromicine(250 mg BD)and Amoxicillin (If Kratinize Cearance is between 10-30:250-500mg BD and if it is less than 10:250-500 mg Daily)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Sari
Full name of responsible person
Dr Atieh Makhlough
Street address
Imam Khomeini Hospital,Amir Mazandarani Boulevard
City
Sari
2
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital of Sari
Full name of responsible person
Dr Atieh Makhlough
Street address
Fatemeh Zahra Hospital, Artesh Boulevar
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Research and Technology, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayati
Street address
Building No. 2 of University, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Research and Technology, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Atieh Makhlough
Position
Associate Professor/Nephrologist
Other areas of specialty/work
Street address
Internal ward, Emam Hospital, Amir Mazandarani Boulevard
City
ُSari
Postal code
Phone
+98 15 1226 4047
Fax
Email
dr.makhloogh@mazums.ac.ir , makhlough_a@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Atieh Makhlough
Position
Associate Professor/Nephrologist
Other areas of specialty/work
Street address
Internal ward, Emam Hospital, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 15 1226 4047
Fax
Email
makhlough_a@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Atieh Makhlough
Position
Associate Professor/Nephrologist
Other areas of specialty/work
Street address
Emam Hospital, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 15 1226 4047
Fax
Email
dr.makhloogh@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)