Effects of probiotics on the incidence of Ventilator-Associated Pneumonia in Intensive Care Unit Patients.
Design
A clinical trial with a control group, parallel groups, single blind, randomized, phase 3
Settings and conduct
Patients suffered from respiratory failure who has invasive airways who need mechanical ventilation in intensive care units randomly will be divided into two groups of intervention and control.
In the intervention group, patients will take contents of Lactocare capsule via a naso-gastric tube.
in the control group, patients will take contents of starch capsule via the naso-gastric tube as a placebo.
Blinding: patients do not know the kind of prescribed drugs
Participants/Inclusion and exclusion criteria
Need to more than 48 hours of mechanical ventilation;
No respiratory infection before initiation of mechanical ventilation;
Need to invasive airways;
No history or any sign and symptoms of any kind of immune deficiency.
Intervention groups
Intervention group: prescription of Lactocare capsule as a probiotic for evaluation of its effects on the reduction of incidence of ventilator-associated pneumonia
Control group: prescription of the starch capsule as a placebo for comparison to the intervention group
Main outcome variables
Fever, leukocytosis, new lung infiltration in chest x-ray, signs of lung consolidation on auscultation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140129016415N7
Registration date:2019-12-03, 1398/09/12
Registration timing:registered_while_recruiting
Last update:2019-12-03, 1398/09/12
Update count:0
Registration date
2019-12-03, 1398/09/12
Registrant information
Name
Mohammad Golparvar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3220 1750
Email address
golparvar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effects of probiotics on incidence of Ventilator Associated Pneumonia in Intensive Care Unit Patients
Public title
evaluation effects of probiotics on ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Need to more than 48 hours of mechanical ventilation
No respiratory infection before initiation of mechanical ventilation
Need to invasive airways
Exclusion criteria:
History or any sign and symptoms of any kind of immune deficiency
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by computer-generated random numbers, patients according to the computer-generated random list will divide into the study and control group. (numbers lower than 0.5 in the study group and numbers greater than 0.5 in the control group).
Blinding (investigator's opinion)
Not blinded
Blinding description
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 Sciences
Street address
No.100, Jahan-nama valley, Babalrahmeh street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8136656433
Approval date
2017-06-16, 1396/03/26
Ethics committee reference number
IR.mui.REC.1396.3.261
Health conditions studied
1
Description of health condition studied
Ventilator associated pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified
Primary outcomes
1
Description
Pneumonia
Timepoint
Daily (at 8 AM) till end of mechanical ventilation
Method of measurement
Auscultation of lungs by stethoscope, measuring body temperature by thermometer, chest x ray
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Prescription of Lactocare Capsule, a mixed preparation of useful bacteria (lactobacils, Bifidobacils, Streptococcus), prepared by Zist Takhmir Pharmaceutical Company (Tehran-Iran), each 12 hours content of one capsule solve in 100 ml of water and gavage by nasogastric tube.
Category
Prevention
2
Description
Control group: Prescription of Placebo Capsule filled by starch, each 12 hours content of one capsule solve in 100 ml of water and gavage by nasogastric tube.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Fereshteh Raufi
Street address
No.100, Jahan nama valley, Babalrahmeh street, Isfahn, Iran
City
Isfahan
Province
Isfehan
Postal code
8136656433
Phone
+98 31 3220 1750
Email
golparvar@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo
Street address
No.4 Headquarters building, Isfahan university of Medical Sciences, hezarjarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.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
Mohammad Golparvar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.100, Jahan nama valley, Babalrahmeh street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8136656433
Phone
+98 31 3220 1750
Email
golparvar@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Golparvar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.100, Jahan nama valley, Babalrahmeh street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8136656433
Phone
+98 31 3220 1750
Email
golparvar@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Golparvar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.100, Jahan nama valley, Babalrahmeh street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
813 6656433
Phone
+98 31 3220 1750
Email
golparvar@med.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