The aim of this study was to determine the effect of eradication of Helicobacter pylori infection on thrombocytopenia in patients with cirrhosis.
This study was a clinical trial with one group before and after intervention. 23 cirrhotic patients who had immunoglobin anti- Helicobacter pylori antibodies and platelet count less than 85000/µl were included. This study was performed in Imam Reza Hospital of Mashhad University of Medical Sciences from 2011 to 2013 with easy sampling. Eradication of Helicobacter pylori infection was done with amoxycillin 1000 mg, omperazole 20 mg, and clarithromycine 500 mg twice daily for 2 weeks. Eradication of Helicobacter pylori infection was confirmed 4 weeks after treatment by urea breath test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020112333N1
Registration date:2013-10-14, 1392/07/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-14, 1392/07/22
Registrant information
Name
Ali Mokhtarifar
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 5335
Email address
mokhtarifara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2010-06-12, 1389/03/22
Expected recruitment end date
2013-01-07, 1391/10/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To assess the effect of Helicobacter pylori infection eradication on thrombocytopenia in patients with cirrhosis
Public title
The effect of helicobacter pylori infection eradication on thrombocytopenia in patients with Liver failure.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with thrombocytopenia due to cirrhosis of the liver;
platelet count was less than 85,000 per micro liter; The immunoglubin anti- Helicobacter pylori antibodies were positive.
Exclusion criteria at the beginning: History of previous treatment for Helicobacter pylori infection eradication; treatment with proton pump inhibitors or antibiotics in the past four weeks; History of allergy drugs for eradicate of Helicobacter pylori infection.
Exclusion criteria during the study: allergy to drugs; Helicobacter pylori infection are not eradicated after treatment.
Age
From 17 years old to 72 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
23
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Building Qureshi , University Street
City
Mashhad
Postal code
Approval date
2010-05-12, 1389/02/22
Ethics committee reference number
88653
Health conditions studied
1
Description of health condition studied
Thrombocytopenia in cirrhotic patients
ICD-10 code
D69.5
ICD-10 code description
Secondary thrombocytopenia
Primary outcomes
1
Description
Thrombocytopenia
Timepoint
Before and 4 weeks after the end of treatment.
Method of measurement
Venous blood samples
Secondary outcomes
empty
Intervention groups
1
Description
Amoxycillin 1000 mg, omperazole 20 mg, and clarithromycine 500 mg twice daily for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Ali Mokhtarifar (MD)
Street address
Ibn Sina Street East
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi(MD)
Street address
Building Qureshi , University Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hooman Mosannan Mozaffari
Position
Gastroenterology Fellowship/ Assistant professor
Other areas of specialty/work
Street address
Ibn Sina Street East, Imam Reza Hospital, Department of Internal medicine
City
Mashhad
Postal code
9137913316
Phone
+98 51 1859 8818
Fax
Email
MozaffariH@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Mokhtarifar
Position
Gastroenterologist/ Assistant professor
Other areas of specialty/work
Street address
Ibn Sina Street East, Imam Reza Hospital, Department of Internal medicine
City
Mashhad
Postal code
9137913316
Phone
+98 51 1859 8818
Fax
+98 85 98818
Email
Mokhtarifara@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Mokhtarifar
Position
Gastroenterologist
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)