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Comparison of the effect of Helicobacter Pylori eradication regimens in patients with end stage renal disease

Protocol summary

Summary
Objectives: The aim of this study is to compare the effect of Helicobacter Pylori (HP) eradication regimens in patients with end stage renal disease (ESRD). Design: 120 patients with end stage renal disease and confirmed HP infection using upper endoscopy will be select random and will receive eradication regimens in four groups. Inclusion criteria: Patients with end stage renal disease and helicobacter pylori infection. Exclusion criteria: pregnancy, liver failure, patient with active cancer, recent using of Proton pomp inhibitors, Non steroidal anti inflammatory drugs, bismuth and antibiotics during last four weeks, history of alcohol abuse, cigarette smoking and any drug reactions . Intervention: the patients will be divided to four groups according to 2-week eradication regimens; Group I: RCA (clarithromycin 250 mg-BD, amoxicillin 500 mg-BD, rabeprazole 20 mg-BD), Group II: RCM (clarithromycin 250 mg-BD, metronidazole 500 mg-BD, rabeprazole 20 mg-BD), Group III: RCAM (clarithromycin 250 mg-BD, metronidazole 500 mg-BD, amoxicillin 500 mg-BD, rabeprazole 20 mg-BD) and Group IV: Sequential (rabeprazole 20 mg-BD, first week; amoxicillin 500 mg-BD and second week; clarithromycin 250 mg-BD, metronidazole 500 mg-BD. Main outcome measures: Four weeks after treatment end, Urea Breath Test (UBT) that will be an indicator for eradication of H.P. will perform for all patients and the results will compare in the groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015081123591N1
Registration date: 2015-09-01, 1394/06/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-01, 1394/06/10
Registrant information
Name
Peyman Sanjari Pirayvatlou
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 6240
Email address
dr.p.sanjari@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Golestan university of medical sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Helicobacter Pylori eradication regimens in patients with end stage renal disease
Public title
The comparison of the efficacy of four different therapeutic regimens against Hlicobacter pylori infection in End Stage Renal Disease patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All ESRD patients with confirmed H.pylori infection using Endoscopic gasterodeodenoscopy with complete consciousness of patient about research. Exclusion criteria: Pregnancy, liver failure, patient with active cancer, recent using of Proton pomp inhibitors, Non steroidal anti inflammatory drugs, bismuth and antibiotics during last four weeks, history of alcohol abuse, cigarette smoking and any drug reactions.
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
the patients will be selected among the end stage renal disease individuals with helicobacter pylori in a simple random selection.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Golestan university of medical sciences
Street address
Central organization of Golestan University of Medical sciences, next to Anjirab, Hirkan boulevard
City
Gorgan
Postal code
4918936316
Approval date
2014-03-16, 1392/12/25
Ethics committee reference number
39459212254

Health conditions studied

1

Description of health condition studied
Helicobacter pylori infection
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
Helicobacter pylori
Timepoint
4 weeks after finishing of treatment course
Method of measurement
Patients swallow urea labelled with an uncommon isotope, either radioactive carbon-14 or non-radioactive carbon-13. In the subsequent 10–30 minutes, the detection of isotope-labelled carbon dioxide in exhaled breath indicates that the urea was split; this indicates that urease (the enzyme that H. pylori uses to metabolize urea) is present in the stomach, and hence that H. pylori bacteria are present

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group 1: RCA regimen ( capsule Clarythromycin 250 mg every 12 hours, capsule Amoxicillin 500 mg every 12 hours, tablet Rabeprazole 20 mg every 12 hours)
Category
Treatment - Drugs

2

Description
Intervention group 3: RCAM regimen (capsule Clarythromycin 250 mg every 12 hours, capsule Amoxicillin 250 mg every 12 hours, tablet Rabeprazole 20 mg every 12 hours, tablet Metronidazole 500 mg every 12 hours)
Category
Treatment - Drugs

3

Description
Intervention group 4: sequential regimen (tablet Rabeprazole 20 mg every 12 hours, first week; capsule Amoxicillin 500 mg every 12 hours and second week; capsule Clarithromycin 250 mg every 12 hours,tablet Metronidazole 500 mg every 12 hours)
Category
Treatment - Drugs

4

Description
Intervention group 2: RCM regimen (capsule Clarythromycin 250 mg every 12 hours, tablet Metronidazole 500 mg every 12 hours, tablet Rabeprazole 20 mg every 12 hours)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
5th. Azar hospital
Full name of responsible person
Dr. Peyman Sanjari Pirayvatlou
Street address
next to 6th.Azar avenu, 5th. Azar street
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Golestan university of medical sciences
Full name of responsible person
Dr.Mohsen Saeedi
Street address
Central organization of Golestan university of medical sciences, next to Anjirab, Hirkan boulevard
City
Gorgan
Grant name
129007
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Golestan 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
Golestan University of Medical Scienced
Full name of responsible person
Dr. Peyman Sanjari Pirayvatlou
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Central Organization of Golestan University of Medical Sciences, next to Anjirab, Hirkan boulevard
City
Gorgan
Postal code
Phone
+98 17 3247 0110
Fax
Email
dr.p.sanjari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan university of medical sciences
Full name of responsible person
Dr.Mohamadreza Seyedmajidi
Position
Gastroenterologist
Other areas of specialty/work
Street address
Central organization of Golestan University of Medical Sciences, next to Anjirab, Hirkan boulevard
City
Gorgan
Postal code
Phone
+98 17 3247 0110
Fax
Email
mrsmajidi@goums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golestan University of Medicalsciences
Full name of responsible person
Dr. Peyman Sanjari Pirayvatlou
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Central Organization of Golestan University of Medical Sciences, next to Anjirab, Hirkan boulevard
City
Gorgan
Postal code
Phone
+98 17 3247 0110
Fax
Email
dr.p.sanjari@gmail.com
Web page address

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
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