Protocol summary
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Study aim
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To determine the effects of enteral probiotics on inflammatory markers and prognostic scores in the critically ill trauma patients
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Design
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This is a double-blind, randomized phase 3 clinical trial on 80 critically ill trauma patients. Stratified randomization is used.
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Settings and conduct
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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 1 and day 8. The study is double-blind and the primary researcher, nurses, patients, and data analyzers will be blind to the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients who are admitted to the ICU due to multiple 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 with an APACHE II score of more than 34 (mortality rate of 85% and higher).
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Intervention groups
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Two capsules of LactoCare from Zist Takhmir 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.
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Main outcome variables
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The primary outcomes of the study will be to assess the changes in CRP and patient prognostic scores such as APACHE II, SOFA, and SAPS on days 1 and 8 of the intervention between the two groups. 28-day mortality and time to discharge will also be assess at the end of the study.
General information
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Reason for update
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A minor change in the study title - Designation of trial end date - Omission of one of the exclusion criteria as it was not done before randomization but instead excluded after the intervention started.
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Acronym
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PROTIN
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IRCT registration information
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IRCT registration number:
IRCT20211006052684N1
Registration date:
2021-10-19, 1400/07/27
Registration timing:
prospective
Last update:
2023-01-07, 1401/10/17
Update count:
5
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Registration date
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2021-10-19, 1400/07/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-10-23, 1400/08/01
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Expected recruitment end date
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2023-01-21, 1401/11/01
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Actual recruitment start date
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2021-11-08, 1400/08/17
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Actual recruitment end date
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2022-12-25, 1401/10/04
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Trial completion date
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2022-12-25, 1401/10/04
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Scientific title
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Effect of enteral probiotics on prognostic scores and C-reactive protein levels in critically ill multiple trauma patients: A double-blind placebo-controlled randomized clinical trial
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Public title
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Effect of probiotics on multiple trauma patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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 with an APACHE II score of more than 34 (mortality rate of 85% and higher)
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Stratified randomization based on sex and APACHE II scores will be used and a random list will be generated using Excel. The random list of will be generated using the random function of Excel software. The person giving the intervention will not have access to the list and after list generation, drugs/placebo, anonymously, will be handed over to the person involved in intervention allocation.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-09-26, 1400/07/04
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Ethics committee reference number
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IR.MUI.MED.REC.1400.507
Health conditions studied
1
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Description of health condition studied
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Traumatic patients
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ICD-10 code
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T07
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ICD-10 code description
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Unspecified multiple injuries
Primary outcomes
1
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Description
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Quantitative C-reactive protein (QCRP)
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Timepoint
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Before and 7 days after the beginning of intervention.
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Method of measurement
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Laboratory Kit
2
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Description
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The Acute Physiology and Chronic Health Evaluation II score (APACHE II)
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Timepoint
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Before and 7 days after the beginning of intervention.
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Method of measurement
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Based on the APACHE II score table
3
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Description
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The Simplified Acute Physiology Score (SAPS II)
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Timepoint
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Before and 7 days after the beginning of intervention.
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Method of measurement
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Based on the SAPS II score table
4
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Description
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Sequential Organ Failure Assessment (SOFA)
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Timepoint
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Before and 7 days after the beginning of intervention.
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Method of measurement
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Based on the SOFA score table
Secondary outcomes
1
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Description
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28-day mortality
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Timepoint
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28 days after the start of the intervention
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Method of measurement
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Questionnaire
2
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Description
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Time to discharge
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Timepoint
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At the time of patient discharge
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Method of measurement
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Total days from the start of intervention to discharge
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available