The effects of Synbiotics on preventing Antibiotic Associated Diarrhea
Design
Clinical Trial with control group, with parallel groups, blinded, Ranomized
Settings and conduct
This study is done in Imam Hosein Hospital in Isfahan city. Admitted patients with 2 months to 14 years ages that are candidate for Antibiotic therapy are treated with Synbiotic or placebo. Drops with contents of Synbiotic or placebo are produced by pharmacology factory and special codes are allocated for each drop and researcher and patients do not have any information about drop contents. Treatment is started 24 hours after Antibiotic therapy and continue for 7 days after finishing Antibiotic therapy and patients are evaluated for presence of diarrhea every 3 days. Patients are followed for 21 days after finishing Antibiotic therapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) 2 months to 14 years age, 2) Admitted in Imam Hosein Hospital, 3) Candidate for Antibiotic therapy due to infection for equal and more than 5 days, 4) Parent's willingness
Exclusion criteria: 1)Chronic or acute diarrhea before starting Antibiotics, 2) Recent Antibiotic therapy during last 2 months, 3) Recent prophylactic Antibiotic use, 4) Underlying diseases, 5) Central vein catheterization, 6) Recent use of probiotics
Intervention groups
Intervention group: Patients receiving Synbiotic 24 hours after starting Antibiotic therapy and continue 7 days after finishing treatment.
Control group: Patients receiving Placebo 24 hours after starting Antibiotic therapy and continue 7 days after finishing treatment.
Main outcome variables
Number of defecation; Stool consistency; Incidence of diarrhea; Diarrhea duration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171119037543N2
Registration date:2018-02-03, 1396/11/14
Registration timing:registered_while_recruiting
Last update:2018-02-03, 1396/11/14
Update count:0
Registration date
2018-02-03, 1396/11/14
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 894 5212
Email address
m.goli@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effects of Synbiotic on Preventing Antibiotic Associated Diarrhea in children admitted in Imam Hosein Hospital in Isfahan City
Public title
Synbiotic and Antibiotic Associated Diarrhea
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children with 2 months to 14 years age
Children who are admitted in Imam Hosein Hospital in Isfahan City
Children who are candidate for Antibiotic therapies due to infections for equal and more than 5 days
Parent's willingness to participating in this study
Exclusion criteria:
Acute or chronic diarrhea before starting Antibiotic
Having Antibiotic therapy during last 2 months
Having prophylactic Antibiotic treatment
Having Clostridium Difficile Associated Diarrhea during last 3 months
Having underlying gastrointestinal disease
Having central vein catheterization
Having history of using probiotics during last 7 days
Having immune deficiency
Having underlying cardiovascular disease
Having sever malnutrition or sever illness
Having long term use of medications with gastrointestinal effects
Age
From 2 months old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The type of randomization in this study is Block Randomization. In this study, Synbiotic and placebo are produced in drop forms with same shapes by pharmacology factory and get to researchers. The factory allocates an special code for each drop and researcher and patients do not have any information about the contents of drops. A table is planned and the name of patient and his/ her drop code are registered. In analyzing time, these codes and drop contents are get from factory and data are analyzed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, researcher and patients do not have any information about contents of drops.
Drops with Synbiotics and placebo are produced by pharmacology factory in same shape and special codes are allocated for each drop. The contents of drops are get from factory in analyzing time.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
Imam Hosein Hospital, Imam Khomeini Street
City
Isfahan
Province
Isfehan
Postal code
8195163381
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.MUI.REC.1396.3.374
Health conditions studied
1
Description of health condition studied
Antibiotic Associated Diarrhea
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Number of defecation
Timepoint
Every 3 days after starting Antibiotic treatment to 21 days after finishing Antibiotic treatment
Method of measurement
Interview with parents
2
Description
Stool Consistency
Timepoint
Every 3 days after starting Antibiotic treatment to 21 days after finishing Antibiotic treatment
Method of measurement
Bristol Stool Scale questionnaire
3
Description
Incidence of diarrhea
Timepoint
Every 3 days after starting Antibiotic treatment to 21 days after finishing Antibiotic treatment
Method of measurement
Interview with parents
4
Description
Diarrhea duration
Timepoint
Every 3 days after starting Antibiotic treatment to 21 days after finishing Antibiotic treatment
Method of measurement
Interview with parents
Secondary outcomes
1
Description
Incidence of constipation
Timepoint
Every 3 days after starting Antibiotic treatment to 21 days after finishing Antibiotic treatment
Method of measurement
Interview with parents
2
Description
Presence of blood in stool
Timepoint
Every 3 days after starting Antibiotic treatment to 21 days after finishing Antibiotic treatment
Method of measurement
Interview with parents
Intervention groups
1
Description
Intervention group: Synbiotic powder (Protexin Restore), Starting 24 hours after starting Antibiotic therapy until 7 days after finishing Antibiotic therapy, One sachet daily, produced by Protexin Health Care Company
Category
Prevention
2
Description
Control group: Placebo in powder shape, Starting 24 hours after starting Antibiotic therapy until 7 days after finishing Antibiotic therapy, One sachet daily, produced by faculty of Pharmacy in Isfahan University of Medical Science
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hosein Hospital
Full name of responsible person
Hamid Rahimi
Street address
Imam Hosein Hospital, Imam Khomeini Street
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
m.goli@resident.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian
Street address
Isfahan University of Medical Science, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
M.goli@resident.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mozhgan Goli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Isfahan University of Medical Science, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 894 5212
Fax
+98 31 4251 3905
Email
m.goli@resident.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Rahimi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Isfahan University of Medical Science, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
m.goli@resident.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mozhgan Goli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Isfahan University of Medical Science, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 894 5212
Fax
+98 31 4251 3905
Email
m.goli@resident.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available