Comparison efficacy the three- drug regimen of Helicobacter Pylori eradication Amoxicillin, Omeprazole, with Clarithromycin or Azithromycin in children
Objective: The comparison of the therapeutic effect of Azithromycin instead of Clarithromycin concerning the eradication of Helicobacter Pylori [H.pylori] with tolerance in children and triple therapy accompanying Omeprazole and Amoxicillin.
Inclusion Criteria: Two to 15 year-old children who refer to Amirkola Hospital with gastrointestinal symptoms associated with Helicobacter Pylori [H.pylori] whose stomach’s biopsy diagnosed Helicobacter Pylori.
Exclusion Criteria: The use of antibiotic since 2 months earlier; children beyond 2 to 15 years of age; drug allergies to medications during the study compared; chronic liver and renal diseases.
The subjects of the study: The children who refer to Children’s Digestive Clinic of Amirkola Children’s Hospital.
The sample size: Sixty subjects were divided into two groups of 30.
The study duration: Within 2014
Intervention of the study: A group of Omeperazole manufatured by Abidie Company 1mg/kg/day every 12 hours for two weeks. Amoxicillin manufactured by Farabi Company 50 mg/kg/day every 12 hours for 10 days. Clarithromycin manufactured by Chemidarou and Rouzdarou Company 15 mg/kg/day every 12 hours for 10 days.
Omeprazole and Amoxicillin were given on the same condition in the other group and Azithromycin manufactured by Tehran Shimi and Kharazmy 10 mg/kg/day once a day for 6 days.
Primary outcome: The evaluation of response to treatment within 4 to 6 weeks after the treatment is done and the measurement of Helicobacter Pylori Antigen in stool in monoclonol style with quick antigen of helicobactor kit from Germany and drug tolerance status and its complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112115475N1
Registration date:2014-10-07, 1393/07/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-07, 1393/07/15
Registrant information
Name
Hossein Shirdel
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3235 4951
Email address
shierdel.h@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2014-04-30, 1393/02/10
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison efficacy the three- drug regimen of Helicobacter Pylori eradication Amoxicillin, Omeprazole, with Clarithromycin or Azithromycin in children
Public title
The Eradication of Helicobacter Pylori [H.pylori] in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Two to 15 year old children with gastrointestinal symptoms associated with Helicobacter Pylori that need upper Gastro Intestinal whose Gastric biopsy diganosed Helicobacter Pylori Endoscopy and have been referred to the Amirkola Children’s Hospital.
Exclusion criteria: Use of antibiotics 2 months ago; children beyond ages of 2 to 15 years; drug allergies to medications used in the study; chronic liver and renal disease; taking non steroidal anti inflammatory drugs; patients who have been previously treated for Helicobacter Pylori.
Age
From 2 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
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
Babol University of Medical Sciences
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran.
City
Babol
Postal code
4717647745
Approval date
2014-04-22, 1393/02/02
Ethics committee reference number
4018.30.ژ.پ
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
The detection Status of Helicobacter Pylori antigen in stool
Timepoint
Four to 6 weeks after the treatment is over
Method of measurement
Check on the stool antigen from Helicobacter Pylori point of view in a Monoclonal Method with Helicobacter Antigen Quick kit
Secondary outcomes
1
Description
The status of drug tolerance and side effects
Timepoint
Within treatment till the end of treatment span
Method of measurement
Check on the Helicobacter Pylori stool antigen
Intervention groups
1
Description
Intervention 1: Azithromycin manufactured by Tehran Shimi Company and Khrazmi 10 mg/kg/day once a day for 6 days using with Amoxicillin manufactured by Farabi Company 50 mg/kg/day every 12 hours for 10 days and Omeprazole developed by Abidy Company 1 mg/kg/day every 12 hours for two weeks.
Category
Treatment - Drugs
2
Description
Intervention 2: Clarithromycin developed by Chemidarou and Rouzdarou Company 15 mg /kg/day every 12 hours for 10 days using with Amoxicillin and Omeprazole.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola Children’s Hospital
Full name of responsible person
Dr Mohammadreza Esmaeili
Street address
No 19, Amirkola Children’s Hospital, Amirkola.
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Vice- Chancellor for Research Technology Affairs
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street.
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Amirkola Children’s Hospital
Full name of responsible person
Hossein Shirdel
Position
Pediatric Assistant
Other areas of specialty/work
Street address
No 19, Amirkola Children’s Hospital, Amirkola.
City
Babol
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
dr.h.shirdel@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Amirkola Children’s Hospital
Full name of responsible person
Dr Mohammadreza Esmaeili
Position
Pediatric Gastroenterologist
Other areas of specialty/work
Street address
No 19, Amirkola Children’s Hospital, Amirkola.
City
Babol
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
esmaeilidooki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Amirkola Children’s Hospital
Full name of responsible person
Hossein Shirdel
Position
pediatric Assistant
Other areas of specialty/work
Street address
No 19, Amirkola Children’s Hospital, Amirkola.
City
Babol
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
dr.h.shirdel@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)