Determining the role of probiotics in reduction of ICU patients' infections
Design
Two arm parallel group randomized trial on ICU patients, not blinded , simple randomization according to the Random numbers table
Settings and conduct
The study is conducted on 100 patients admitted to ICU who are not suffering from pneumonia or pulmonary involvement. The patients are randomly divided into two groups of 50. One group - in addition to prescription drugs and antibiotics- are given probiotics as prophylaxis of ventilator associated pneumonia(VAP), and the other only receives medications prescribed by a specialist. Ventilator associated pneumonia will be examined in two groups .
Participants/Inclusion and exclusion criteria
Age over 18 years , length of stay in ICU for more than 5 days, absence of diarrhea within 48 hours before admission, lack of immune deficiency history, lack of regular treatment with probiotics before admission, non pregnant
Intervention groups
One group - in addition to prescription drugs and antibiotics - are given probiotics as prophylaxis of pneumonia associated with ventilation (VAP), and the other only receives medications prescribed by the specialist.
Main outcome variables
ventilator associated pneumonia , age , probiotic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170704034901N2
Registration date:2018-05-29, 1397/03/08
Registration timing:registered_while_recruiting
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3244 4453
Email address
rezaeemaliheh@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of probiotic effects on prophylaxis of ventilator – associated pneumonia in ICU patients
Public title
investigation of probiotic effects on prophylaxis of pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age over than 18 year
Length of stay in ICU for more than 5 days
Exclusion criteria:
Diarrhea at first visit or 48 hours before admission
immune deficiency
Regular treatment with probiotics before admission
pregnancy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method , using the Random numbers table , individual randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari ave
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2018-02-06, 1396/11/17
Ethics committee reference number
Ir.bums.REC.1396.337
Health conditions studied
1
Description of health condition studied
Ventilator associated pneumonia(VAP)
ICD-10 code
J15
ICD-10 code description
Bacterial pneumonia, not elsewhere classified
Primary outcomes
1
Description
The incidence of ventilator associated pneumonia(VAP)
Timepoint
Up to 15 days after starting probiotics, ventilator-associated pneumonia will be examined.
Method of measurement
Daily hematologic examination (CBC and neutrophil count), active phase proteins (CRP or proxlotonin or ferritin) and chest X ray, Based on the American College of Chest Physicians clinical criteria, new or sustained infiltration in the CXR with 2 or 3 of the following findings: fever (.38.58C or ,35.08C), leukocytosis (white bloodcells . 10,000/mm3 or ,3,000/mm3), and purulent sputum.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receive the first dose of probiotics during the first 24 hours of intubation and, until extubation or up to 10 days after the intubation, every 12 hours, one tablet of vitalact (each tablet contains 10〗 9 CFU of lactobacillus gasseri, Bifidobacterium bifidum, Bifidobacterium longum and multivitamin And mineral. Of Iran's Bioscience Company).
Category
Prevention
2
Description
Control group: This group does not take any special medication.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital, Imam Reza Hospital
Full name of responsible person
Maliheh Rezaei
Street address
Imam Reza Hospital, Taleghani Ave., Razi Hospital, Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
rezaeemaliheh@bums.ac.ir
Web page address
http://www.bums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
Birjand University of Medical Sciences, Ghaffari ave
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3244 0388
Fax
+98 56 3244 0388
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr. Farshid Abedi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Birjand University of Medical Sciences, Ghaffari ave
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 5600
Fax
+98 56 3244 0447
Email
abedifar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Farshid Abedi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Birjand University of Medical Sciences, Ghaffari ave
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 5600
Fax
+98 56 3244 0447
Email
abedifar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maliheh Rezaei
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 84,Modares 30,Modares Street,Birjand
City
Birjand
Province
South Khorasan
Postal code
9718685191
Phone
+98 56 3244 4453
Email
rezaeemaliheh@gmail.com
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