Comparative evaluation of sequential therapy versus triple therapy and concomitant four-drug therapy for eradication of helicobacter pylori infection in children from 5 to 15 years old
The aim of this study is to compare the evaluation of sequential therapy versus triple therapy and concomitant four drug therapy for eradication of Helicobacter pylori infection in children with gastrointestinal disorders. Inclusion criteria will be included: patients with digestive disorders such as recurrent abdominal pain; gastrointestinal bleeding and dyspepsia. Exclusion criteria will be included: having a history of taking medications such as antibiotics; bismuth; proton pump inhibitors; Histamine receptor antagonists and non steroid anti inflammatory drugs in the last 4 weeks. The study population will be included all children from 5 to 15 years old with gastrointestinal disorders. The sample size will be 120 patients. Intervention and its time will be included: treatment in group A with Omeprazole plus Amoxicillin plus Clarithromycin over 10 days, treatment in group B with Omeprazole plus Amoxicillin in the first 5 days and then Omeprazole plus Metronidazole plus Clarithromycin over the next 5 days and treatment in group C with Omeprazole plus Amoxicillin plus Clarithromycin plus Metronidazole over 10 days. The primary outcome variables will be included: Helicobacter pylori in the corpus specimen, Histopathology of stomach biopsy, Helicobacter pylori in anther sample, rapid urease test and Helicobacter pylori stool antigen.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062234698N1
Registration date:2017-09-06, 1396/06/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-06, 1396/06/15
Registrant information
Name
Behrooz Kamani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 8709
Email address
b.kamani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of sequential therapy versus triple therapy and concomitant four-drug therapy for eradication of helicobacter pylori infection in children from 5 to 15 years old
Public title
Drug therapy of Helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with digestive disorders such as recurrent abdominal pain; gastrointestinal bleeding and dyspepsia.
Exclusion criteria: having a history of taking medications such as antibiotics; bismuth; proton pump inhibitors; Histamine receptor antagonists and non steroid anti inflammatory drugs in the last 4 weeks.
Age
From 5 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd., Qazvin
City
Qazvin
Postal code
59811-34197
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
IR.QUMS.REC.1396.118
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
Helicobacter pylori in the corpus specimen
Timepoint
Four weeks after the last day of treatment
Method of measurement
Standard protocol
2
Description
Histopathology of stomach biopsy
Timepoint
Four weeks after the last day of treatment
Method of measurement
Standard protocol
3
Description
Helicobacter pylori in anther sample
Timepoint
Four weeks after the last day of treatment
Method of measurement
Standard protocol
4
Description
Rapid urease test
Timepoint
Four weeks after the last day of treatment
Method of measurement
Standard protocol
5
Description
Helicobacter pylori stool antigen
Timepoint
Four weeks after the last day of treatment
Method of measurement
Standard protocol
Secondary outcomes
1
Description
Body mass index
Timepoint
Four weeks after the last day of treatment
Method of measurement
Body mass index formula
Intervention groups
1
Description
Group A: Omeprazole plus Amoxicillin plus Clarithromycin over ten days
Category
Treatment - Drugs
2
Description
Group B: Omeprazole plus Amoxicillin in the first five days and then Omeprazole plus Metronidazole plus Clarithromycin over the next five days
Category
Treatment - Drugs
3
Description
Group C: Omeprazole plus Amoxicillin plus Clarithromycin plus Metronidazole over ten days