To determine the effects of enteral probiotics on inflammatory markers and prognostic scores in the critically ill trauma patients
Design
This is a double-blind, randomized phase 3 clinical trial on 80 critically ill trauma patients. Block randomization is used.
Settings and conduct
The study will take place in the ICU of Alzahra hospital in Isfahan, Iran from 23rd of October 2021 for 15 months. After randomization and assessment of baseline data the intervention will start for 7 days. Primary outcomes will be assessed on day 10. The study is triple blind and the primary researcher, nurses, patients, and data analyzers will be blind to the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who are admitted to the ICU due to trauma; patients older than 18 and younger than 70 years of age; patients who are expected to stay in the ICU for more than 7 days.
Exclusion criteria: patients who do not consent to participate in the study; patients who have an absolute contraindication for enteral feeding; pregnant patients; patients who are planned to have a surgery during the study; patients who are discharged from the ICU or die during the study; patients who are unable to tolerate of finish the intervention due to any cause; patients with an APACHE II score of more than 35 (mortality rate of 85% and higher).
Intervention groups
Two capsules of Lactocare from Zisttakhmir pharmaceuticals will be given to each patient every 12 hours in the intervention group for 7 days. Placebo will be given to the control group at an identical dose and time.
Main outcome variables
The primary outcomes of the study will be to assess the changes in inflammatory markers such as ESR and CRP and patient prognostic scores such as APACHE II, SOFA, and SAPS on days 1 and 10 of the intervention between the two groups. 28-day mortality will also be assess at the end of the study.
General information
Reason for update
Acronym
PROTIN
IRCT registration information
IRCT registration number:IRCT20211006052684N1
Registration date:2021-10-19, 1400/07/27
Registration timing:prospective
Last update:2021-10-19, 1400/07/27
Update count:5
Registration date
2021-10-19, 1400/07/27
Registrant information
Name
Amirhossein Akhavan Sigari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 8092
Email address
amirsigari@aol.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of enteral probiotics on inflammatory markers and prognostic scores in the critically ill trauma patients
Public title
Effect of probiotics on trauma-induced inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are admitted to the intensive care unit (ICU) due to trauma
Patients older than 18 and younger than 70 years
Patients who are expected to stay in the ICU for 7 days or more
Exclusion criteria:
Patients who do not consent to participate in the study.
Patients who have absolute contraindication to enteral feeding or the use of probiotics.
Pregnant patients
Patients who are planned to have a surgery.
Patients with an APACHE II score of more than 34 (mortality rate of 85% and higher)
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be used and a random list based on blocks of 2 will be generated using Excel. The random list of blocks will be generated using the random function of Excel software. The person giving the intervention will not have access to the list and after creation of the blocks, drugs/placebo, anonymously, will be handed over to the person.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs and placebo will be kept with a person who is not involved in patient selection and allocating the intervention. After enrolment of qualified individuals based on inclusion and exclusion criteria, drug/placebo boxes will be released to the person giving the intervention. After data analysis, the placebo and intervention group will be revealed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
Alzahra University Hospital, Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2021-09-26, 1400/07/04
Ethics committee reference number
IR.MUI.MED.REC.1400.507
Health conditions studied
1
Description of health condition studied
Traumatic patients
ICD-10 code
T07
ICD-10 code description
Unspecified multiple injuries
Primary outcomes
1
Description
Quantitative C-reactive protein (QCRP)
Timepoint
Before and 10 days after the beginning of intervention.
Method of measurement
Laboratory Kit
2
Description
1 hour Erythrocyte Sedimentation Rate (ESR)
Timepoint
Before and 10 days after the beginning of intervention.
Method of measurement
Laboratory
3
Description
The Acute Physiology and Chronic Health Evaluation II score (APACHE II)
Timepoint
Before and 10 days after the beginning of intervention.
Method of measurement
Using the online calculator: https://www.mdcalc.com/apache-ii-score
4
Description
The Simplified Acute Physiology Score (SAPS II)
Timepoint
Before and 10 days after the beginning of intervention.
Method of measurement
Using the online calculator: https://www.mdcalc.com/simplified-acute-physiology-score-saps-ii
5
Description
Sequential Organ Failure Assessment (SOFA)
Timepoint
Before and 10 days after the beginning of intervention.
Method of measurement
Using the online calculator: https://www.mdcalc.com/sequential-organ-failure-assessment-sofa-score
Secondary outcomes
1
Description
28-day mortality
Timepoint
28 days after the start of the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Two Lactocare probiotic capsules from Zisttakhmir pharmaceuticals will be given to the intervention group every 12 hours for a total of 7 days. The route of administration will be oral or by a nasogastric tube. Each Lactocare capsule contains fructooligosaccharide as prebiotic and Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, and Streptococcus thermophilus as the probiotic blend (probiotic blend: 10^9 colony forming unit (CFU)). The total number of capsules given to each patient for the total intervention time will be 28 capsules.
Category
Treatment - Drugs
2
Description
Control group: two placebo capsules identical to the original Lactocare probiotic capsules will be given to each patient in the control group every 12 hours for a total of 7 days. The placebo capsules will be provided by Zisttakhmir Pharmaceutical company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra University Hospital
Full name of responsible person
Saeed Abbasi
Street address
Alzahra University Hospital, Soffe Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 8092
Email
s_abbasi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmardi
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave.
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
Amirhossein Akhavan Sigari
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Alzahra University Hospital, Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 8092
Fax
Email
amirsigari@aol.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amirhossein Akhavan Sigari
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Alzahra University Hospital, Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 8092
Fax
Email
amirsigari@aol.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amirhossein Akhavan Sigari
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Alzahra University Hospital, Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 8092
Fax
Email
amirsigari@aol.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