Objectives: Purpose of this study is to introduce a more successful therapy for Helicobacter pylori infection in children by comparing sequential and standard therapy.
Study design: uni-center, randomized controlled trial without placebo control,
Participants: Sixty children referred to endoscopy ward in Children's Medical Center for investigation of Helicobacter pylori infection
Inclusion criteria: 1- Gastrointestinal symptoms 2- Helicobacter pylori infection documented by pathology or rapid urease test 3- Age above 2 years
Exclusion criteria: 1- Drug consumption including acid Suppressor drugs and antibiotics during last 4 weeks 2- Hypersensitivity to antibiotics
Intervention: After completing the questionnaire about patient's data and gastrointestinal symptoms; all the patients which have Helicobacter pylori infection will be randomized to group 1 (intervention, sequential therapy) and group 2 (control, standard therapy). The patients number in each group approximately is 30. Group 1 will receive omeprazole plus amoxicillin given for the first 5 days followed by a triple therapy including omeprazole, clarithromycin and metronidazole for the remaining 5 days. Group 2 will receive triple therapy by omeprazole plus amoxicillin and metronidazole for 10 days. Treatment continues in both groups by omeprazole until 1 month from initiation of therapy.
Main outcome measures: One month after cessation of therapy, Helicobacter pylori stool antigen test will be performed to determine Helicobacter pylori eradication.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122515929N1
Registration date:2014-03-13, 1392/12/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-13, 1392/12/22
Registrant information
Name
Parisa Rashtian
Name of organization / entity
Children's Medical Center, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 1029
Email address
p-rashtian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-02-19, 1392/11/30
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sequential and standard therapy in Helicobacter pylori eradication in children
Public title
Efficacy of sequential and standard therapy on Helicobacter pylori eradication in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Gastrointestinal symptoms including epigastric tenderness,abdominal pain without reason or at night, pain increase after feeding,early satiety, weight loss without reason, recurrent vomiting, iron deficiency anemia without reason
2- Helicobacter pylori infection documented by pathology or rapid urease test
3- Age below 14 and above 2 years
Exclusion criteria:
1- Drug consumption including proton pomp inhibitor, histamine blockers, bismuth containing drugs and antibiotics during last 4 weeks
2- History of gastric surgery
3- Hypersensitivity to antibiotics
4-Previous known underlying diseases including renal failure or endocrine diseases
Age
From 2 years old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulevard
City
Tehran
Postal code
14155/6447
Approval date
2012-05-17, 1391/02/28
Ethics committee reference number
1007/م/11
Health conditions studied
1
Description of health condition studied
Helicobacter pylori
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 eradication
Timepoint
Before intervention and 2 months after intervention (1 month after cessation of treatment)
Method of measurement
Pathology or rapid urease test (Baharafshan Co.) on the specimen taken during endoscopy before treatment and fecal antigen test of Helicobacter pylori (G.E.N.E.S.I.S , UK) after treatment
Secondary outcomes
1
Description
Treatment Side Effects
Timepoint
2 Weeks After Beginning of Treatment
Method of measurement
Questionnaire
2
Description
Endoscopic presentations of Helicobacter pylori
Timepoint
Before intervention
Method of measurement
Endoscopic view recorded in questionnaire
Intervention groups
1
Description
Intervention 1: The sequential regimen is a dual therapy including omeprazole (Dr. Abidi Co.) 1mg/Kg plus amoxicillin (Farabi Co.) 25mg/Kg (both twice daily) given for the first 5 days followed by a triple therapy including omeprazole (1mg/Kg ), clarithromycin (Chemidarou Co.) 7.5mg/Kg and metronidazole (Tehranshimi Co.) 10mg/Kg (all twice daily) for the remaining 5 days. Omeprazole continues until 30 days from initiating the treatment.
Category
Treatment - Drugs
2
Description
Intervention 2 (Control): Triple therapy with omeprazole (DR. Abidi Co.) 1mg/Kg(30 days), plus amoxicillin (Farabi Co.) 25mg/Kg (10 days)and metronidazole (Tehranshimi Co.) 10mg/Kg (10 days).all drugs use twice a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children 's Medical Center Hospital
Full name of responsible person
Parisa Rashtian
Street address
No.62, Dr. Gharib Street, end of Keshavarz Boulevard
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masood Yunesian
Street address
Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulevard
City
Tehran
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Masood Unesian
Position
Vice chancellor for research, Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulevard
City
Tehran
Postal code
141556447
Phone
+98 21 8896 2510
Fax
Email
chmc@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Children' Medical Center
Full name of responsible person
Fatemah Farahmand
Position
Pediatric Gastroenterologist, Full Professor
Other areas of specialty/work
Street address
Children's Medical Center, No.62, Dr. Gharib Street, end of Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 21 61475
Fax
Email
chmc@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Children's Medical Center
Full name of responsible person
Parisa Rashtian
Position
Pediatrician, Fellowship of Pediatric Gastroenterology
Other areas of specialty/work
Street address
Children's Medical Center, No.62,ّ Dr. Gharib Street, end of Keshavarz Boulevard
City
Tehran
Postal code
1419733151
Phone
+98 21 61475
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)