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Protocol summary
This is a double-blind, randomized phase 3 clinical trial on 80 critically ill trauma patients. Block randomization is used.
This is a double-blind, randomized phase 3 clinical trial on 80 critically ill trauma patients. Stratified randomization is used.
This is a double-blind, randomized phase 3 clinical trial on 80 critically ill trauma patients. BlockStratified randomization is used.
کارآزمایی بالینی با گروه کنترل و تصادفی سازی شده، دو سو کور، فاز ۳ بر روی ۸۰ بیمار ترومایی بستری در آی سی یو. برای تصارفی سازی از روش بلوک های ۲ تایی و فانکشن rand نزم افزار اکسل استفاده میشود.
کارآزمایی بالینی با گروه کنترل و تصادفی سازی شده، دو سو کور، فاز ۳ بر روی ۸۰ بیمار ترومایی بستری در آی سی یو. برای تصارفی سازی از روش طبقه بندی شده و فانکشن rand نزم افزار اکسل استفاده میشود.
کارآزمایی بالینی با گروه کنترل و تصادفی سازی شده، دو سو کور، فاز ۳ بر روی ۸۰ بیمار ترومایی بستری در آی سی یو. برای تصارفی سازی از روش بلوک های ۲ تاییطبقه بندی شده و فانکشن rand نزم افزار اکسل استفاده میشود.
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).
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 who are discharged from the ICU or die during the study; patients with an APACHE II score of more than 34 (mortality rate of 85% and higher).
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 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 3534 (mortality rate of 85% and higher).
معیار های ورود مطالعه برای شرکت کنندگان شامل:
１- بیمارانی که به علت تروما در آی سی یو بیمارستان بستری شدهاند
２- بیماران بالای ۱۸ سال و زیر ۷۰ سال
３- بیمارانی که انتظار میرود که هفت روز یا بیشتر در آی سی یو حضور داشته باشند
معیار های خروج از مطالعه برای شرکت کنندگان شامل:
１- بیمارانی که رضایت جهت شرکت در مطالعه را ندادهاند.
２- بیمارانی که هر گونه کنترااندیکاسیون تغذیهی روده ای یا دریافت مداخله دارند.
３- بیمارانی که حامله هستند.
４- بیمارانی که در زمان انجام مداخله برنامه جراحی برای آنها نتظیم شده است.
５- بیمارانی که در طول مدت دریافت مداخلات فوت میکنند یا مرخص می شوند.
６- بیمارانی که به هر علت دیگری قادر به دریافت و اتمام مداخله نباشند.
７- بیماران با نمره APACHE II بیشتر از ۳۴ (مورتالیته ۸۵٪ به بالا)
معیار های ورود مطالعه برای شرکت کنندگان شامل:
１- بیمارانی که به علت تروما در آی سی یو بیمارستان بستری شدهاند
２- بیماران بالای ۱۸ سال و زیر ۷۰ سال
３- بیمارانی که انتظار میرود که هفت روز یا بیشتر در آی سی یو حضور داشته باشند
معیار های خروج از مطالعه برای شرکت کنندگان شامل:
１- بیمارانی که رضایت جهت شرکت در مطالعه را ندادهاند.
２- بیمارانی که هر گونه کنترااندیکاسیون تغذیهی روده ای یا دریافت مداخله دارند.
３- بیمارانی که حامله هستند.
4- بیمارانی که به هر علت دیگری قادر به دریافت و اتمام مداخله نباشند.
5- بیماران با نمره APACHE II بیشتر از ۳۴ (مورتالیته ۸۵٪ به بالا)
معیار های ورود مطالعه برای شرکت کنندگان شامل: １- بیمارانی که به علت تروما در آی سی یو بیمارستان بستری شدهاند ２- بیماران بالای ۱۸ سال و زیر ۷۰ سال ３- بیمارانی که انتظار میرود که هفت روز یا بیشتر در آی سی یو حضور داشته باشند معیار های خروج از مطالعه برای شرکت کنندگان شامل: １- بیمارانی که رضایت جهت شرکت در مطالعه را ندادهاند. ２- بیمارانی که هر گونه کنترااندیکاسیون تغذیهی روده ای یا دریافت مداخله دارند. ３- بیمارانی که حامله هستند. ４- بیمارانی که در زمان انجام مداخله برنامه جراحی برای آنها نتظیم شده است. ５- بیمارانی که در طول مدت دریافت مداخلات فوت میکنند یا مرخص می شوند. ６4- بیمارانی که به هر علت دیگری قادر به دریافت و اتمام مداخله نباشند. ７5- بیماران با نمره APACHE II بیشتر از ۳۴ (مورتالیته ۸۵٪ به بالا)
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.
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.
Two capsules of LactocareLactoCare from ZisttakhmirZist 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.
General information
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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.
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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تغییر جزیی در تیتر مقاله - تعیین تاریخ پایان نمونه گیری و خاتمه مطالعه - حذف یکی از معیار های خروج به این علت که قبل از تصارفی سازی نبوده است.
تغییر جزیی در تیتر مقاله - تعیین تاریخ پایان نمونه گیری و خاتمه مطالعه - حذف یکی از معیار های خروج به این علت که قبل از تصارفی سازی نبوده است.
Effect of probiotics on trauma-induced inflammation
Effect of probiotics on multiple trauma patients
Effect of probiotics on multiple trauma-induced inflammation patients
بررسی اثر پروبیوتیک بر التهاب ناشی از تروما
بررسی اثر پروبیوتیک ها در بیماران مولتیپل تروما
بررسی اثر پروبیوتیک بر التهاب ناشی ازها در بیماران مولتیپل تروما
The effect of enteral probiotics on inflammatory markers and prognostic scores in the critically ill trauma patients
Effect of enteral probiotics on C-reactive protein levels and prognostic scores in the critically ill multiple trauma patients
The effectEffect of enteral probiotics on inflammatory markersC-reactive protein levels and prognostic scores in the critically ill multiple trauma patients
بررسی اثر پروبیوتیک های خوراکی بر معیار های التهابی و معیارهای سنجش وضعیت بیمار در بیماران ترومایی بستری در آی سی یو
بررسی اثر پروبیوتیک های خوراکی بر CRP کمی و معیارهای سنجش وضعیت بیمار در بیماران ترومایی بستری در آی سی یو
بررسی اثر پروبیوتیک های خوراکی بر معیار های التهابیCRP کمی و معیارهای سنجش وضعیت بیمار در بیماران ترومایی بستری در آی سی یو
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)
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)
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)
بیمارانی که رضایت جهت شرکت در مطالعه را ندادهاند.
بیمارانی که هر گونه کنترااندیکاسیون تغذیهی روده ای یا دریافت مداخله دارند.
بیمارانی که حامله هستند.
بیمارانی که در روزهای انحام مطالعه برنامه ی حراخی برای آنها تنظیم شده است.
بیماران با نمره APACHE II بیشتر از ۳۴ (مورتالیته ۸۵٪ به بالا)
بیمارانی که رضایت جهت شرکت در مطالعه را ندادهاند.
بیمارانی که هر گونه کنترااندیکاسیون تغذیهی روده ای یا دریافت مداخله دارند.
بیمارانی که حامله هستند.
بیماران با نمره APACHE II بیشتر از ۳۴ (مورتالیته ۸۵٪ به بالا)
بیمارانی که رضایت جهت شرکت در مطالعه را ندادهاند. بیمارانی که هر گونه کنترااندیکاسیون تغذیهی روده ای یا دریافت مداخله دارند. بیمارانی که حامله هستند. بیمارانی که در روزهای انحام مطالعه برنامه ی حراخی برای آنها تنظیم شده است. بیماران با نمره APACHE II بیشتر از ۳۴ (مورتالیته ۸۵٪ به بالا)
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.
Stratified randomization based on sex and APACHE II scores will be used and a random list will be generated using Excel. The random list 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.
BlockStratified randomization based on sex and APACHE II scores 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 blockslist generation, drugs/placebo, anonymously, will be handed over to the person involved in intervention allocation.
نحوه تصادفی سازی به صورت بلوک های ۲ تایی خواهد بود. لیست راندوم بلوک ها توسط شخص ثالثی با استفاده از نرم افزار اکسل تهیه شده و محرمانه می ماند. بعد از انتخاب بیماران، دارو و دارو نما بدون اینکه قابل تشخیص باشند به فرد محقق تحویل داده میشود.
نحوه تصادفی سازی به صورت طبقه بندی شده بر اساس جنس و معیار آپاچی هواهد بود. لیست راندوم توسط شخص ثالثی با استفاده از نرم افزار اکسل تهیه شده و محرمانه می ماند. بعد از انتخاب بیماران، دارو و دارو نما بدون اینکه قابل تشخیص باشند به فرد محقق تحویل داده میشود.
نحوه تصادفی سازی به صورت بلوک های ۲ تایی خواهدطبقه بندی شده بر اساس جنس و معیار آپاچی هواهد بود. لیست راندوم بلوک ها توسط شخص ثالثی با استفاده از نرم افزار اکسل تهیه شده و محرمانه می ماند. بعد از انتخاب بیماران، دارو و دارو نما بدون اینکه قابل تشخیص باشند به فرد محقق تحویل داده میشود.
Primary outcomes
#1
Using the online calculator: https://www.mdcalc.com/apache-ii-score
Based on the APACHE II score table
UsingBased on the online calculator: https://www.mdcalc.com/apache-ii-APACHE II score table
با استفاده از وبسایت : https://www.mdcalc.com/apache-ii-score
محاسبه بر اساس جدول
با استفاده از وبسایت : https://www.mdcalc.com/apache-ii-scoreمحاسبه بر اساس جدول
#2
معیار SAPS
معیار SAPS II
معیار SAPS II
Using the online calculator: https://www.mdcalc.com/simplified-acute-physiology-score-saps-ii
Based on the SAPS II score table
UsingBased on the online calculator: https://www.mdcalc.com/simplified-acute-physiology-SAPS II score-saps-ii table
با استفاده از وبسایت: https://www.mdcalc.com/simplified-acute-physiology-score-saps-ii
محاسبه بر اساس جدول
با استفاده از وبسایت: https://www.mdcalc.com/simplified-acute-physiology-score-saps-iiمحاسبه بر اساس جدول
#3
Using the online calculator: https://www.mdcalc.com/sequential-organ-failure-assessment-sofa-score
Based on the SOFA score table
UsingBased on the online calculator: https://www.mdcalc.com/sequential-organ-failure-assessment-sofa-SOFA score table
با استفاده از وبسایت: https://www.mdcalc.com/sequential-organ-failure-assessment-sofa-score
محاسبه بر اساس جدول
با استفاده از وبسایت: https://www.mdcalc.com/sequential-organ-failure-assessment-sofa-scoreمحاسبه بر اساس جدول
Protocol summary
Study aim
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. Stratified 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 8. The study is double-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 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 who are discharged from the ICU or die during the study; patients with an APACHE II score of more than 34 (mortality rate of 85% and higher).
Intervention groups
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.
Main outcome variables
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 will also be assess at the end of the study.
General information
Reason for update
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.
Acronym
PROTIN
IRCT registration information
IRCT registration number:IRCT20211006052684N1
Registration date:2021-10-19, 1400/07/27
Registration timing:prospective
Last update:2022-12-25, 1401/10/04
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
2021-11-08, 1400/08/17
Actual recruitment end date
2022-12-25, 1401/10/04
Trial completion date
2022-12-25, 1401/10/04
Scientific title
Effect of enteral probiotics on C-reactive protein levels and prognostic scores in the critically ill multiple trauma patients
Public title
Effect of probiotics on multiple trauma patients
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 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
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization based on sex and APACHE II scores will be used and a random list will be generated using Excel. The random list 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.
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 7 days after the beginning of intervention.
Method of measurement
Laboratory Kit
2
Description
The Acute Physiology and Chronic Health Evaluation II score (APACHE II)
Timepoint
Before and 7 days after the beginning of intervention.
Method of measurement
Based on the APACHE II score table
3
Description
The Simplified Acute Physiology Score (SAPS II)
Timepoint
Before and 7 days after the beginning of intervention.
Method of measurement
Based on the SAPS II score table
4
Description
Sequential Organ Failure Assessment (SOFA)
Timepoint
Before and 7 days after the beginning of intervention.
Method of measurement
Based on the SOFA score table
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
Kashani University Hospital
Full name of responsible person
Saeed Abbasi
Street address
Kashani St., Kashani University Hospital
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
s_abbasi@med.mui.ac.ir
Web page address
https://kashani.mui.ac.ir
2
Recruitment center
Name of recruitment center
Alzahra University Hospital
Full name of responsible person
Saeed Abbasi
Street address
Soffe Blvd., Alzahra University Hospital.
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