Effect of a probiotic supplementation, Lactocare, on gut microbiota in critically ill septic patients admitted to intensive care units
Design
En Clinical trial with intervention and control groups, with parallel groups, Double-blind, randomized trial
Settings and conduct
En All patients admitted to ICUs of Shohada and Imam Reza Hospitals , who are undergoing mechanical ventilation and require the insertion of NGT, will be included in this study. Patients will randomly be assigned to probiotic and control groups. Participants and the person who will analyze the data collected during the study will be kept blind to study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All critically ill septic patients admitted to intensive care units. Exclusion criteria:
Intervention groups
En All patients in intervention group will receive enteral capsules of Lactocare (1 capsule/12h) for 10 days in addition to standard ICU treatment.
Main outcome variables
Gut microbiota in critically ill septic patients admitted to intensive care units
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002582N19
Registration date:2018-05-09, 1397/02/19
Registration timing:prospective
Last update:2018-05-09, 1397/02/19
Update count:0
Registration date
2018-05-09, 1397/02/19
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a probiotic supplementation, Lactocare, on gut microbiota in critically ill septic patients admitted to intensive care units
Public title
Effect of a Lactocare, on gut microbs in critically ill septic patients admitted to intensive care units
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Need for enteral nutrition
Age over 18 years old
Age under 70 years old
Exclusion criteria:
age under 18 years old
age over 70 years old
pregnancy
lactating
previous history of lactocare use
Long-term administration of systemic corticosteroid
History of alcohol consumption
History of intestinal surgery in a recent month
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Patients are randomly assigned into two groups by block randomization.
Randomization is done based on the Grav O tron2.0 software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants, the main researcher, the health care staff (doctors, nurses, etc.) responsible for patient care, data collection authorities, those who evaluate the outcome, and those who prepare the draft article. Have been kept blind to the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central Building No. 2, Tabriz University of Medical Sciences, Golghast St,
City
Tabriz
Province
East Azarbaijan
Postal code
5166615953
Approval date
2017-12-04, 1396/09/13
Ethics committee reference number
IR.TBZMED.REC.1396.825
Health conditions studied
1
Description of health condition studied
Other infectious diseases
ICD-10 code
B99.8
ICD-10 code description
Other infectious disease
Primary outcomes
1
Description
Gut microbiota in critically ill septic patients admitted to intensive care units
Timepoint
En days 1th and 10th
Method of measurement
PCR of stool
Secondary outcomes
1
Description
En ICU length of stay
Timepoint
En during ICU stay
Method of measurement
En days that patient is stayed in ICU
Intervention groups
1
Description
Intervention group: En All patients in intervention group will receive enteral capsules of Lactocare (1 capsule/12h) for 10 days in addition to standard ICU treatment.
Category
Treatment - Drugs
2
Description
Control group: All patients in control group will receive standard ICU treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital ICU
Full name of responsible person
Ata Mahmoodpoor
Street address
Shohada hospital, El-goli street
City
Tabriz
Province
East Azarbaijan
Postal code
692
Phone
+98 41 3389 3336
Fax
+98 41 3389 3337
Email
mahmoodpoora@tbzmed.ac.ir
2
Recruitment center
Name of recruitment center
General ICU, Imam Reza hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
Imam Reza hospital, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3332 8009
Email
mahmoodpoora@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Central Building No. 2, Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166615953
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Director of ICU,Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Medicine, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3332 8009
Email
mahmoodpoora@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Director of ICU,Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Medicine, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3332 8009
Email
mahmoodpoora@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roya Ghaemikhiavi
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Tabriz University of Medical Sciences,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 4324
Email
drroyaghaemi@yahoo.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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Study will be reported as paper
When the data will become available and for how long
Not applicable
To whom data/document is available
Not applicable
Under which criteria data/document could be used
Not applicable
From where data/document is obtainable
Not applicable
What processes are involved for a request to access data/document