Comparison of the effect of antibiotic with antibiotic and probiotic combination in the eradication of Helicobacter Pylori infection in children by a randomized clinical trial
The aim of the study is to compare the eradication rate of Helicobacter Pylori infection in patients receiving standard triple-drug treatment with those who receive probiotics in addittion to the standard regimen in children 2-14 years old in Children Medical Center Hospital.
a randomized double blind clinical trial, placebo controlled, single center
Inclusion criteria:
more than 2 and less than 14 years of age; Gastrointestinal symptoms; confirmation of Helicobacter pylori infection by rapid urease test or histopathology.
Exclusion criteria:
The use of proton pump inhibitors, H2 receptor antagonists, , bismuth compounds and antibiotics in the past 4 weeks; The history of surgery on the stomach; Sensitivity to certain types of antibiotics; G6PD enzyme deficiency; known underlying disease.
sample size for each of case and control groups: 33.
All Helicobacter Pylori positive patients are randomized into one of the A and B groups; amoxicillin and furazolidone are given for a week and omeprazole for 4 weeks for all of them. In addition to the standard regimen patients randomly receive either probiotics or placebo for 2 weeks .The fecal antigen test is performed to evaluate the eradication rate at least 4 weeks after discontinuation of omeprazole.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201218793N1
Registration date:2012-04-09, 1391/01/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-09, 1391/01/21
Registrant information
Name
Ahmad Khodadad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 98216692445
Email address
khodadadmd@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-04-18, 1391/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of antibiotic with antibiotic and probiotic combination in the eradication of Helicobacter Pylori infection in children by a randomized clinical trial
Public title
Probiotics in the treatment of Helicobacter Pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: more than 2 and less than 14 years of age; gastrointestinal symptoms including epigastric tenderness, abdominal pain at night, worsening of abdominal pain by eating, early satiety, abdominal pain or weight loss without a known cause, frequent vomiting and Iron deficiency anemia; confirmation of Helicobacter Pylori infection by rapid urease test or histopathology.
Exclusion criteria: use of proton pump inhibitors, H2 receptor antagonists, bismuth compounds and antibiotics in the past 4 weeks; history of surgery on the stomach; sensitivity to certain types of antibiotics; G6PD enzyme deficiency(in these patients the use of furazolidone may lead to anemia ); known underlying disease including renal failure, heart disease or endocrine disease.
Age
From 2 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Headquarter for Tehran University of Medical Sciences, On the Corner of Keshavarz Blvd. and Qods Street, Keshavarz Blvd., Vali-e-Asr Square, Tehran, Iran.
City
Tehran
Postal code
Approval date
2012-01-28, 1390/11/08
Ethics committee reference number
2097
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
Primary outcomes
1
Description
eradication rate of helicobacter pylori
Timepoint
after two months of the treatment
Method of measurement
stool antigen for helicobacter pylori
Secondary outcomes
1
Description
endoscopic finding
Timepoint
at the time of endoscopy
Method of measurement
by the report of the person performing the endoscopy
2
Description
adverse effects of the drugs
Timepoint
during the course of treatment
Method of measurement
subjective /asking the patients and parents
3
Description
concordance of the result of rapid urease test and pathology report
Timepoint
after the pathology report is prepared
Method of measurement
The comparison of the result of urease test with histopathological report by the researchers
Intervention groups
1
Description
In the intervention group Amoxicillin (dose 50 mg / kg / day/divided in 2 doses) and Furazolidone (dose of 6 mg / kg / day/divided in 2 doses) for 1 week and Omeprazole for 4 weeks (with a dose of 1 mg / kg / day/once at morning) are prescribed. Amoxicillin and Furazolidone tablets or syrup forms based on the child's age are given. In addition, patients in this group receive probiotics for 2 weeks. The probiotic is named RESTORE, the product of Protexin company that contains 7 types of probiotics including Lactobacillus Acidophilus, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Lactobacillus Casei, Streptococcus Thermophilus, Bifidobacterium Infantis(child specific), Bifidobacterium breve.
This product is given once daily after breakfast.
Category
Treatment - Drugs
2
Description
In the control group Amoxicillin (dose 50 mg / kg / day/divided in 2 doses) and Furazolidone (dose of 6 mg / kg / day/divided in 2 doses) for 1 week and Omeprazole for 4 weeks (with a dose of 1 mg / kg / day/once at morning) are prescribed. Amoxicillin and Furazolidone tablets or syrup forms based on the child's age are given. In addition to the standard regimen, in the control group, the patients receive placebo in the first 2 weeks. Placebo is a product seeming just like the probiotic and is composed of dextrose. This product is prepared by Protexin company and is prescribed once daily after breakfast similar to the RESTORE probiotic.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center Hospital
Full name of responsible person
Maryam Shoaran
Street address
Endoscopy ward-Children Medical Center,Qarib St, Keshavarz Blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Khodadad
Street address
Children Medical Center Hospital, Qarib St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Maryam Shoaran
Position
Pediatrician-Fellowship of Pediatric Gastroenterology
Other areas of specialty/work
Street address
Endoscopy Ward, Children Medical Center Hospital,Qarib St, Keshavarz Blvd