Researchures inclined to use probiotics in order to prevent AAD so that they can achieve better compliance in completen the course of antibiotic therapy.The aim of this randomized,placebo-controlled,double-blind trial was to assess the efficacy of probiotic protexin for prevention of AAD. from may 2010 to november 2011 , a total of 219 patients(aged 6 months to 14 years) with respiratory tract infection/and or otitis media who had begun receiving antibiotics were randomized to receive protexin or placebo for 7 days.patients mother recorded bowel frequency and stool consistency daily for 7 days. control group receiving placebo quite similar to probiotics but without any effect of probiotic.Probiotic and placebo packages As a daily Sasht To ten days for the patients are randomly and The code is recorded in a questionnaire.Parents are also given a questionnaire to give information about Patient,Stool consistency,Stools per day and the possible occurrence of fever,Vomiting and bloody diarrhea associated with antibiotics can reduce the risk of diarrhea,Until these issues in the event The patient should be excluded.Then at 3 and 7 days of antibiotic and probiotic or placebo,Presence Or telephone Information was obtained from parents and is recorded to be used in the final assessment. The primary outcome was the proportion of patients who developed AAD within 7days of enrollment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205229828N1
Registration date:2012-07-09, 1391/04/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-09, 1391/04/19
Registrant information
Name
Rasoul Alimi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
8544633 و 8544643
Email address
alimir901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-11-21, 1390/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effects of probiotics in the prevention of antibiotic-associated diarrhea in children
Public title
Study the effects of probiotics in the prevention of antibiotic-associated diarrhea in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Children 6 months to 14 years ; Due to upper respiratory infection or ear infection ; Referred to in the first 24 hours of starting antibiotics Exclusion criteria: Severe infection or bacterial genaralyze ; Antibiotic treatment within 2 months before treatment ; Antibiotic prophylaxis; The use of probiotic products in recent months;Known immunodeficiency; Chronic intestinal infection; Acute and chronic diarrhea; Use more than one type of antibiotic treatment during the period; Heart or lung disease or severe renal, Lactase deficiency is known; viral gastroenteritis (rotavirus) ; Passing blood in the stool,Vomiting with diarrhea and severe dehydration;Incorrect or incomplete use of antibiotics ; failure to complete treatment course
Age
To 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
230
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
Mashhad University of Medical Sciences-Ghaem Hospital
Street address
parastar st.- Ahmedabad Avenue
City
Mashhad
Postal code
99199-91766
Approval date
2011-01-01, 1389/10/11
Ethics committee reference number
89454
Health conditions studied
1
Description of health condition studied
Diarrhea
ICD-10 code
A09
ICD-10 code description
Other gastroenteritis and colitis of infectious and unspecified origin
Primary outcomes
1
Description
Diarrhea
Timepoint
Over a period of more than three loose stools in 48 hours
Method of measurement
Question of the mother
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group receiving Probiotic packages As a daily Prvtksyn Sasht To ten days .Probiotics contain a billion or a phrase such as Sasht 10*9 live microorganisms that are considered for each patient is 10 to 10 days and The code is recorded in a questionnairer.Parents are also given a questionnaire to give information about Patient,Stool consistency,Stools per day and the possible occurrence of fever,Vomiting and bloody diarrhea associated with antibiotics can reduce the risk of diarrhea,Until these issues in the event The patient should be excluded.Then at 3 and 7 days of probiotic ,Presence Or telephone Information was obtained from parents and is recorded to be used in the final assessment.
Category
Treatment - Drugs
2
Description
The control group received a placebo that are quite similar with probiotic. The control group receiving Placebo packages As a daily Prvtksyn Sasht To ten days .Placebo are considered for each patient is 10 to 10 days and The code is recorded in a questionnairer.Parents are also given a questionnaire to give information about Patient,Stool consistency,Stools per day and the possible occurrence of fever,Vomiting and bloody diarrhea associated with antibiotics can reduce the risk of diarrhea,Until these issues in the event The patient should be excluded.Then at 3 and 7 days of placebo ,Presence Or telephone Information was obtained from parents and is recorded to be used in the final assessment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr.ali khakshoor
Street address
parastar st., Ahmedabad Avenue
City
MASHHAD
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali jafari
Street address
Ghaem hospital, parastar st., Ahmedabad Avenue
City
MASHHAD
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Ghaem Hospital
Full name of responsible person
Simin Partovi
Position
Assistant Professor of Pediatrics
Other areas of specialty/work
Street address
parastar st., Ahmedabad Avenue
City
Mashhad
Postal code
99199-91766
Phone
+98 51 1840 0001
Fax
Email
partovis@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Jafari
Position
Gastroenterologist
Other areas of specialty/work
Street address
Ghaem hospital, parastar st., Ahmedabad Avenue
City
Mashhad
Postal code
99199-91766
Phone
+98 51184000019
Fax
Email
jafaria@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Simin Partovi
Position
Assistant Professor of Pediatrics
Other areas of specialty/work
Street address
parastar st., Ahmedabad Avenue
City
Mashhad
Postal code
Phone
+98 51 1840 0001
Fax
Email
partovis@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)