the goal of this study is to improve treatment results of helicobacter pylori infection in children and to suggest a new treatment method for this infection.every student between 9-12 year have the inclusion criteria and the exclusion criterias are disagreement to be a participant,significant GI sign and symptom,antibiotic usage in the last month,history of antacid usage,diarrhea at the time of sampling,history of immunodeficiency,history of any drug or food allergy, and antibiotic usage during the time of intervention.the study population is asymptomatic students with positive results of stool antigen that has been detected in screening previously.sample size of 20 for each group(intervention and control) considered and sampling will be done randomly from the population.the intervention is treatment with capsules of dried saccharomycess boulardi with Yomogi trade name.both intervention and placebo groups receive medication for 1 month.follow up with telephone contacts will be done.at the end of this time stool analysis for Helicobacter pylori stool antigen will be done once again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052117791N1
Registration date:2014-06-23, 1393/04/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-23, 1393/04/02
Registrant information
Name
Fatemeh Basirinejad
Name of organization / entity
Birjand University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 56 1882 5000
Email address
fateme.basiri@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Science
Expected recruitment start date
2014-06-08, 1393/03/18
Expected recruitment end date
2014-06-15, 1393/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Role of saccharomycess boulardi in eradication of Helicobacter Pylori infection in 9-12 year old asymptomatic children live in Birjand
Public title
Role of probiotics on eradication of helicobacter pylori in children
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:9-12 year old children who study in Birjands grade schools
exclusion criteria: dissatisfaction in cooperation;significant gastrointestinal sign and symptom;antibiotic usage in previous month;history of antiacid usage(PPI or H2 blocker);diarrhea at the time of sampling;history of any immunodeficiency;any kind of food and drug allergy; use of antibiotics for other diseases in time of intervention in case and control group
Age
From 9 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Science
Street address
ghaffari street,birjand,iran
City
Birjand
Postal code
Approval date
2014-05-04, 1393/02/14
Ethics committee reference number
05-02-1393
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B98.0
ICD-10 code description
B98.0 Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Primary outcomes
1
Description
H.pylori stool antigen
Timepoint
before and at the end of intervention
Method of measurement
quantitative in microgram/ml
Secondary outcomes
1
Description
incidence of diarrhea due to intervention
Timepoint
at the end of intervention
Method of measurement
questionnaire
2
Description
incidence of improvement in weight gaining due to intervention
Timepoint
at the end of intervention
Method of measurement
questionnaire
3
Description
incidence of improvement in bowel habit due to intervention
Timepoint
at the end of intervention
Method of measurement
questionnaire
4
Description
incidence of vomitting due to intervention
Timepoint
at the end of interventin
Method of measurement
questionnaire
5
Description
incidence of flatulence due to intervention
Timepoint
at the end of intervention
Method of measurement
questionnaire
6
Description
incidence of fever due to intervention
Timepoint
at the end of intervention
Method of measurement
questionnaire
7
Description
incidence of abdominal pain due to intervention
Timepoint
at the end of intervention
Method of measurement
questionnaire
8
Description
incidence of other bad effects due to intervention
Timepoint
at the end of intervention
Method of measurement
questionnaire
9
Description
incidence of improvement in appetite due to intervention
Timepoint
at the end of intervention
Method of measurement
questionnaire
10
Description
incidence of other good effects due to intervention
Timepoint
at the end of intervention
Method of measurement
qustionnaire
11
Description
incidence of nausea due to intervention
Timepoint
at the end of intervention
Method of measurement
questionnaire
Intervention groups
1
Description
yomogi,250mg capsules contain dried yeast of saccharromyces boulardi,once daily,for one month
Category
Treatment - Drugs
2
Description
placebo,250mg capsules contain lactose and starch powder,once daily,for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
maryam female grade school
Full name of responsible person
Mrs Behdani the school manager
Street address
Adl street,Birjand
City
Birjand
2
Recruitment center
Name of recruitment center
Emam Hosein female grade school
Full name of responsible person
Street address
Moallem street, birjand
City
Birjand
3
Recruitment center
Name of recruitment center
Atefe female grade school
Full name of responsible person
Mrs Kamal the school manager
Street address
Samadi street,Birjand
City
Birjand
4
Recruitment center
Name of recruitment center
Younes Fatemi female grade school
Full name of responsible person
Mrs Namakin the school manager
Street address
14 alley, zafar street,Birjand
City
Birjand
5
Recruitment center
Name of recruitment center
Behesht female grade school
Full name of responsible person
Mrs Eslami health teacher
Street address
Mehr shahr
City
Birjand
6
Recruitment center
Name of recruitment center
Roghaye female grade school
Full name of responsible person
Mrs Ansari fard the school manager
Street address
Shahid beheshti street
City
Birjand
7
Recruitment center
Name of recruitment center
Gol narges female grade school
Full name of responsible person
Mrs tavakkoli the school manager
Street address
8th alley, sadaf street,Birjand
City
Birjand
8
Recruitment center
Name of recruitment center
Shahed female grade school
Full name of responsible person
Street address
City
Birjand
9
Recruitment center
Name of recruitment center
Sama male grade school
Full name of responsible person
Mr ghafuri the school manager
Street address
Moallem street
City
Birjand
10
Recruitment center
Name of recruitment center
Hakim Nazari male grade school
Full name of responsible person
Mr Rabi the school manager
Street address
Hakim Nazari street
City
Birjand
11
Recruitment center
Name of recruitment center
Barkat male grade school
Full name of responsible person
Mrs Eslami the health teacher
Street address
Mehr shahr
City
Birjand
12
Recruitment center
Name of recruitment center
Darololum male grade school
Full name of responsible person
Mr Hasani the school manager
Street address
Sadaf street
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Science
Full name of responsible person
Dr Zarban,assistant of deputy of research and technology of Birjand university of medical science
Street address
Ghaffari street, birjand
City
Birjand
Grant name
Grant code / Reference number
718
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Science
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
Birjand University of Medical Science
Full name of responsible person
Fatemeh Basirinejad
Position
pediatric disease assistant
Other areas of specialty/work
Street address
number 258,12th alley,seyed razi street,Vakil abad avenue,Mashhad,IRAN