Objectives:To evaluate the efficacy of the sequential therapy and comparing it with another treatment regimens that was done in this center for eradication of H.pylori, in order to select a treatment regimen that is most effective with least adverse effects.
Inclusion criteria: age < 18 years; gastrointestinal symptoms with suspected H.pylori infection; abdominal pain; nausea; vomiting; halitosis; gastrointestinal bleeding
Patients and Methods: In this study, 40 children with symptoms of H. Pylori that the infection was proved by endoscopy and biopsy and rapid urease test (UBT) were enrolled,
Intervention: Sequential therapy (Lansoprazol, Amoxicillin) for 5 days and (Lansoprazol, Metronidazole and Clarithromycin) for next 5 days.
Main outcome measures: The eradication rate of therapy was evaluated by stool antigen test 6 weeks after completion of therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702179101N3
Registration date:2017-04-23, 1396/02/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-23, 1396/02/03
Registrant information
Name
Seyed Mohsen Dehghani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 1775
Email address
dehghanism@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2015-12-29, 1394/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sequential therapy on treatment of helicobacter pylori in children
Public title
Effect of Sequential Therapy on Treatment of Helicobacter Pylori Infection in Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age < 18 years; gastrointestinal symptoms with suspected H.pylori infection; abdominal pain; nausea; vomiting; halitosis; gastrointestinal bleeding
Exclusion criteria: History of antibiotic consumption
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ehical Comittee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.SUMS.MED.REC.1394.54
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
Eradication of Helicobacter Pylori Infection
Timepoint
Six week after treatment
Method of measurement
Stool antigen
Secondary outcomes
1
Description
Treatment side effect
Timepoint
6 weeks after treatment
Method of measurement
History and physical examination
Intervention groups
1
Description
(Lansoprazol, Amoxicillin) for 5 days and (Lansoprazol, Metronidazole and Clarithromycin) for next 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazee Teaching Hospital
Full name of responsible person
Seyed Mohsen Dehghani
Street address
Dept. of Pediatric Gastroenterology, Nemazee Hospital, Nemazee Sq., Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research Affairs of Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research Affairs of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohsen Dehghani
Position
Professor
Other areas of specialty/work
Street address
Nemazee Hospital,Nemazee Sq., Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3612 5849
Fax
Email
dehghanism@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohsen Dehghani
Position
Professor
Other areas of specialty/work
Street address
Dept. of Pediatric Gastroenterology, Nemazee Hospital, Nemazee Sq., Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3612 5849
Fax
Email
dehghanism@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohsen Dehghani
Position
Professor
Other areas of specialty/work
Street address
Dept. of Pediatric Gastroenterology, Nemazee Teaching Hospital, Nemazee Sq., Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
Fax
Email
Dehghanism@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)