Protocol summary

Summary
Objective: The effect of probiotics in prevention of dysentery in children. Study is a randomized, double-blind intervention study ( RCT). Inclusion criteria: children 6 months to 6 years old who elapsed times of the day in kindergartens of Arak will be entered in study. There will be no gender restrictions. Kindergartens of Arak, some will be selected randomly. Participants were randomly divided into two groups . The first group, five days a week for 3 months will receive probiotic:10** billion cfu Lactobacillus a dose of powder. The second group will receive placebo as powdered gelatin . The sample size in each group will be 100 peoples . Probiotic and placebo will be devide two groups: powder A and powder B . To observe the blindness of those distributing the drug / placebo and also Participants will not be informed of the nature of powders. Then all the subjects during the 3-month incidence of dysentery cases will be assessed. The group receiving drug and group receiving placebo in each nursery case to case will be match. Exclusion criteria:Children who have anymedical condition (including a history of previous lasted diarrhea,malabsorption problems, intestinal polyps, the malnutrition, immune deficiency, a history of Consumption of probiotic compounds, inflammatory bowel disease or chronic disease of the small intestine) or recent (within one month before the study) received antibiotics,the children use antibiotic during taking probiotic or concurrent with other diseases or parental consent to discontinue their cooperation in the project. Children with diarrhea if they need to receive antibiotics and supportive therapy, weight loss over 10% and or requiring hospitalization will be treatment . Time of intervation will be from 03 April 2012 to 05 July 2012. The above informations for each patient individually will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109267647N1
Registration date: 2012-04-10, 1391/01/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-04-10, 1391/01/22
Registrant information
Name
Mehrnaz Adib
Name of organization / entity
Arak university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 5075
Email address
adib@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-07-05, 1391/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotics in prevention of dysentery in children
Public title
The effect of probiotics in prevention of dysentery in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: children 6 months to 6 years old who elapsed times of the day in kindergartens Arak will be entered in this study. There will be no gender restrictions. Kindergartens of Arak, some will be selected randomly. Exclusion criteria: children who have any underlying medical condition (including a history of previous lasted diarrhea,malabsorption problems, intestinal polyps, the malnutrition, immune deficiency, a history of Consumption of probiotic compounds, inflammatory bowel disease or chronic disease of the small intestine) or recent (within one month before the study) received antibiotics ,the children who use antibiotic during taking probiotic or concurrent with other diseases (concomitant illness) or parental consent to discontinue their cooperation in the project .
Age
From 1 year old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
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
Arak university of Medical Sciences
Street address
Arak university of Medical Sciences,Pardis site,Sardasht,Beseig square,Po Box(1884)
City
Arak
Postal code
3848176941
Approval date
2011-08-15, 1390/05/24
Ethics committee reference number
90-111-9

Health conditions studied

1

Description of health condition studied
Dysentery
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin

Primary outcomes

1

Description
Dysentrey
Timepoint
During the 3-month intervention
Method of measurement
Stool Exam or visible blood in the stool

Secondary outcomes

1

Description
prevention of dysentery
Timepoint
during the 3-month intervention
Method of measurement
probability of giving dysentery

Intervention groups

1

Description
Intervention group : five days a week for 3 months with a dose of 10 billion CFU
Category
Prevention

2

Description
Control group:placebo(gelatin powder)
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
kindergartens of Arak city,Iran
Full name of responsible person
Mehrnaz Adib
Street address
Iran-Markazi province-Arak-Amirkabir Hospital
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak university of Medical Sciences
Full name of responsible person
Saiid Changizi Ashtiani
Street address
Arak university of Medical Sciences,Pardis site,Beseij square,Po Box(1884)
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Manijeh Kahbazi
Position
Assistant professor
Other areas of specialty/work
Street address
Arak university of Medical sciences,Infectious diseases & tuberculosis researchs center
City
Arak
Postal code
38196011870
Phone
+98 86 1313 5075
Fax
+98 86 1313 2510
Email
m_kahbazi77@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak university of Medical Sciences
Full name of responsible person
Manijeh Kahbazi
Position
Assistant professor
Other areas of specialty/work
Street address
Arak university of Medical sciences,Infectious diseases & tuberculosis researchs center
City
Arak
Postal code
38196011870
Phone
+98 86 1313 5075
Fax
+98 86 1313 2510
Email
m_kahbazi77@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehrnaz Adib
Position
Residence of Pediatric Diseases
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Pardis Site, Sardasht, Beseij square, PO Box (1884)
City
Arak
Postal code
3819691187
Phone
+98 86 1313 5075
Fax
+98 86 1313 2510
Email
mehrnaz_adib@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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