Our objective is to evaluate effect of sequential therapy in the eradication of H. Pylori infection in uremic patients. 40 patients with age more than 18 years, dyspepsia during last month and positive H.pylori infection (positive rapid urease test and positive biopsy by endoscope) were randomly allocated into two matched (for age and sex) equal groups to treat with either sequential or standard therapy. Standard regimen: Amoxicillin (250-500 mg BD for creatinine clearances 3-10 mg/dl, 250-500 mg Daily for creatinine clearances lower than 10mg/dl), Pantoprazole (40 mg BD) and Claithromycin(250 mg BD). Sequential regimen: Pantoprazole (40mg BD) Amoxicillin (250-500 mg BD for creatinine clearances 3-10mg/dl, 250-500 mg Daily for creatinine clearances lower than 10mg/dl) for the first five days and Clarithromycin (250 mg BD) and Tindazole (500mg BD) and Pantoprazole (40mg BD) for the last five days. Doses were adjusted for creatinine levels. The primary outcome is eradication of H.Pylori measured using stool exam for H.Pylori antigen after 3 months treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706211241N1
Registration date:2009-07-15, 1388/04/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2009-07-15, 1388/04/24
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 and Health Sciences
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sequential therapy with standard therapy for eradication of H.Pylori infection in uremic patients
Public title
Comparison of Sequential therapy with standard therapy for eradication of H.Pylori infection in uremic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 18 years, dyspepsia during last month and positive H.pylori infection (positive rapid urease test and positive biopsy by endoscope).
Exclusion criteria: Antibiotic therapy for eradication of H.pylori, consumption of Proton Pump Inhibitor, H2 blockers, Bismuth, or NSAIDS during last month, consumption of anticoagulants, Ketoconazol or corticosteroids, history of gastric or esophageal surgery, hypersensitivity to antibiotics, negative biopsy of GI, smoking or alcohol use, pregnancy, lactation, severe heart diseases (MI, EF ≤ 30), liver & thyroid diseases and malignancy.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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 and Health Services
Street address
Mazandaran University of Medical Sciences, Imam Sq, Joybar 3 way,
City
Sari
Postal code
Approval date
empty
Ethics committee reference number
88-4
Health conditions studied
1
Description of health condition studied
H. Pylori infection
ICD-10 code
B96.8
ICD-10 code description
Other specified bacterial agents as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Eradication of H. Pylori infection
Timepoint
3 month after treatment
Method of measurement
Stool antigen test
Secondary outcomes
empty
Intervention groups
1
Description
Intrvention group: seqential treatment:Pantoprazole (40mg BD) Amoxicillin (if clearances of cratinin is between 3-10 mg/dl 250-500 mg BD and if it is lower 10mg/dl 250-500 mg Daily, (for the first five days and Claithromycin (250 mg BD) and Tindazole (500mg BD) and Pantoprazole (40mg BD) for the last five days
Category
Treatment - Drugs
2
Description
Control group: Standard regimen: Amoxicillin (if clearances of cratinine is between 3-10 mg/dl 250-500 mg BD and if it is lower 10mg/dl 250-500 mg Daily), Pantoprazole (40 mg BD) and Claithromycin (250 mg BD)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tuba clinic
Full name of responsible person
Atieh Makhlough
Street address
Tuba clinic, Khazar boulevared
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Sayed Jalal Hosseini Mehr
Street address
Moalem sq.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences and Health Services
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 Univercity of Medical Sciences and Health Services
Full name of responsible person
Atieh Makhlough
Position
Associated professor/Aademic staff of mazandaranl univercity of medical sciences
Other areas of specialty/work
Street address
Imam khomaini hospital, Razi St.
City
sari
Postal code
48166-33131
Phone
+98 15 1226 1700
Fax
Email
makhlough_a@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaranl Univercity of Medical Sciences and Health Services
Full name of responsible person
Atieh Makhlough
Position
Nephrologist/Associate Professor/Aademic staff ofmazandaranl univercity of medical sciences
Other areas of specialty/work
Street address
Imam khomani hospital, Razi St.
City
Sari
Postal code
48166-33131
Phone
+98 15 1226 1700
Fax
Email
makhlough_a@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran Univercity of Medical Sciences and Health Services
Full name of responsible person
Atieh Makhlough
Position
Nephrologist/Associated professor Academic Member of Mazandaran Univercity
Other areas of specialty/work
Street address
Imam khomaini hospital, Razi St.
City
Sari
Postal code
48166-33131
Phone
+98 15 1226 1700
Fax
Email
makhlough_a@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)