The aim of the study and study design:
During this study we will use three treatment protocols for eradication of H pylori and we will compare the effectiveness of each protocol on iron reserve.
The study is a randomized controlled trial.
Study population contains patients with dyspepsia and H Pylori infection with low iron reserves who referred to GI clinic of Ali Ibn Abitalib Hospital of Zahedan during 2016.
Inclusion criteria: patients with dyspepsia symptoms who their H pylori infection was proven by endoscopy and biopsy; ferritin serum level less than 40 ng /ml; negative CRP test.
Exclusion criteria: History of treatment of helicobacter pylori during last 6 months; history of iron supplement intake among last 6 months; known underlying diseases associated with iron deficiency; lack of informed consent.
Sample size: 108
Random allocation will apply by balanced block randomization to selection tree groups.
• Control Group: H.Pylori eradication alone for 2 weeks. Drugs for eradication are: furazolidone 200mg/BD, omeprazole 20mg/BD, bismut 240mg/BD, Amoxicillin 1gr/BD.
• Intervention Group 1: H.pylori eradication for 2 weeks and simultaneously start of iron complement for 8 weeks.
• Intervention Group 2: H.pylori eradication for 2 weeks and after ccompleting the eradication, iron complement is used for 8 weeks. Drugs for eradication are : furazolidone 200mg/BD, omeprazole 20mg/BD, bismut 240mg/BD, Amoxicillin 1gr/BD. Iron Complement : ferrous sulfate 300mg/TDS
Project duration: 12 months
Outcome: improve iron status after intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021626593N1
Registration date:2016-10-26, 1395/08/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-26, 1395/08/05
Registrant information
Name
Farhad Yarmohammadi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3348 6260
Email address
frdflower@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of helicobacter pylori eradication on iron stores in patients with dyspepsia
Public title
Effect of gastrointestinal infection eradication on iron stores
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with dyspepsia symptoms who their H pylori infection was proven by endoscopy and biopsy; ferritin serum level less than 40 ng /ml; negative CRP test.
Exclusion criteria: History of treatment of helicobacter pylori during last 6 months; history of iron supplement intake among last 6 months; known underlying diseases associated with iron deficiency; lack of informed consent.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Zahedan, Daneshgah Street, Dr.Hesabi Square, Pardis of Medical University
City
Zahedan
Postal code
Approval date
2015-12-16, 1394/09/25
Ethics committee reference number
IR.ZUMS.REC.1394.374
Health conditions studied
1
Description of health condition studied
Helicobacter Pylori Infection
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
2
Description of health condition studied
Iron Deficiency
ICD-10 code
D50.9
ICD-10 code description
Iron deficiency anemia, unspecified
Primary outcomes
1
Description
Hemoglubin
Timepoint
Before Intervention
Method of measurement
Sysmex K21
2
Description
CRP
Timepoint
Before Intervention
Method of measurement
Latex Aglutination
3
Description
Ferritin
Timepoint
Before and After Intervention
Method of measurement
Eliza Method
Secondary outcomes
1
Description
Ferritin
Timepoint
After Intervention
Method of measurement
Eliza Method
2
Description
Helicobacter Pylori Fecal Antigen
Timepoint
After Intervention
Method of measurement
Stool Examination
Intervention groups
1
Description
Intervention Group :
1- First Group : H.pylori eradication for 2 weeks and simultaneously use of iron complement for 8 weeks.
2- Second Group : H.pylori eradication for 2 weeks and when eradication approved iron complement be used for 8 weeks.
Drugs for eradication are :
furazolidone 200mg/BD, omeprazole 20mg/BD, bismut 240mg/BD, Amoxicillin 1gr/BD.
Iron Complement :
ferrous sulfate 300mg/TDS
Category
Treatment - Drugs
2
Description
Control Group :
H.Pylori eradication alone for 2 weeks.
Drugs for eradication are :
furazolidone 200mg/BD, omeprazole 20mg/BD, bismut 240mg/BD, Amoxicillin 1gr/BD.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences, Ali Ibn Abitalib Hospital
Full name of responsible person
farhad yarmohammadi
Street address
Zahedan, Daneshgah Street, Dr.Hesabi Square, Pardis of Medical University
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
farhad yarmohammadi
Street address
Zahedan, Daneshgah Street, Dr.Hesabi Square, Pardis of Medical University
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
farhad yarmohammadi
Position
Internal medicine resident, executor of plan
Other areas of specialty/work
Street address
Zahedan, Daneshgah Street, Dr.Hesabi Square, Pardis of Medical University
City
Zahedan
Postal code
Phone
+98 54 3348 6260
Fax
+98 54 3348 6260
Email
frdflower@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
farhad yarmohammadi
Position
Internal medicine resident
Other areas of specialty/work
Street address
Zahedan, Daneshgah Street, Dr.Hesabi Square, Pardis of Medical University
City
Zahedan
Postal code
Phone
+98 54 3348 6260
Fax
Email
frdflower@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
farhad yarmohammadi
Position
Internal medicine resident
Other areas of specialty/work
Street address
Zahedan, Daneshgah Street, Dr.Hesabi Square, Pardis of Medical University
City
Zahedan
Postal code
Phone
+98 54 3348 6260
Fax
Email
frdflower@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)