The effect of seven-stroke probiotic supplementation on some of the Thelpers, inflammatory factors and nutritional status changes in patients with head trauma admitted to intensive care unit: a randomized controlled clinical trial
Determining the effect of seven-way probiotic supplement on some Thelpers, inflammatory factors and changes in nutritional status in patients with head trauma, admitted to intensive care unit
Design
Then individuals will be divided into two subgroups of supplement (Iranian lactocare probiotic capsule) and placebo that are similar in shape, size and color to the supplement or using the Block Randomization method and sex-matched. The control group will receive four capsules daily (at 6-hour intervals) and a placebo with the same conditions through a nasopharyngeal tube under completely sterile conditions for 14 days.
Settings and conduct
The study will be performed as a placebo-controlled double-blind clinical trial in patients with head trauma, admitted to the intensive care unit of Imam Reza Hospital and Shohada Hospital. 40 patients with traumatic brain injury with GCS below 8, nasopharyngeal tube feeding and ventilator connected
At the beginning of the study, the cans containing the relevant capsules are coded in A and B by a person other than the researcher, so that the researcher does not know the type of capsules received by each group.
Participants/Inclusion and exclusion criteria
- Age 60-18 years of both sexes
- Low level of consciousness (GCS <8)
- Nutrition through the nasal tube - stomach
- Willingness to cooperate by obtaining the consent of first-degree relatives
Intervention groups
A 40 patients with traumatic brain injury who have GCS below 8, will be fed nasopharyngeal tube and connected to a ventilator
Main outcome variables
Th-17; T-regulatory; Th10; TGF-β; IL-6
IL-1β; length of hospital stay; Damping rate; Respiratory tract infection; Weight ; Height; Body mass index; (BMI) tolerance and improvement of nutritional status; level of consciousness ; Illness severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100209003320N18
Registration date:2020-09-07, 1399/06/17
Registration timing:prospective
Last update:2020-09-07, 1399/06/17
Update count:3
Registration date
2020-09-07, 1399/06/17
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-20, 1399/06/30
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of seven-stroke probiotic supplementation on some of the Thelpers, inflammatory factors and nutritional status changes in patients with head trauma admitted to intensive care unit: a randomized controlled clinical trial
Public title
effect of probiotic on immune system in intensive care unit patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 to 18 years
Low level of consciousness (GCS <8)
Nutrition through the nasal - stomach tube
Willingness to cooperate by obtaining the consent of first-degree relatives
Exclusion criteria:
Pregnancy- Breastfeeding
Parental nutrition (more than two days)
Taking drugs to lower blood sugar, blood lipids and immunosuppressants
Catching of Metabolic, cardiovascular, renal, liver, thyroid, autoimmune and cancer diseases
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
40 eligible patients will be randomly allocated to intervention and placebo groups using a software generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main investigators (including the student and her supervisors and adviser professors), as well as the caregivers and relatives of the patients will be blinded to the type of the supplement (probiotic or placebo) received by each group. The person responsible for preparing the supplement sachets (who is completely unrelated to the study) will be asked to assign a three-digit code to each of the two powders (probiotic and placebo) and keep the codes for himself until the end of the study and data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Lack of effect of probiotics on T cells
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neishabouri Ave, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-08-10, 1399/05/20
Ethics committee reference number
IR.TBZMED.REC.1399.503
Health conditions studied
1
Description of health condition studied
Head Trauma
ICD-10 code
G44.31
ICD-10 code description
Acute post-traumatic headache
Primary outcomes
1
Description
Thelper , Treg cells AND inflammatory factors
Timepoint
Baseline and 7, 14 days after intervention
Method of measurement
Flowcytometry
2
Description
Inflammatory indices
Timepoint
Baseline and 7, 14 days after intervention
Method of measurement
Measurement of serum IL-10 , TGF-β , IL-6 and IL-1β by ELISA
3
Description
Duration of hospitalization and rate of attenuation
Timepoint
Daily
Method of measurement
Observation and questionnaire
4
Description
Respiratory tract infection
Timepoint
Baseline and 7, 14 days after intervention
Method of measurement
Sputum Culture
5
Description
Tolerance and improvement of nutritional status
Timepoint
Daily
Method of measurement
Professional Nutritional Assessment Form
Secondary outcomes
1
Description
Level of consciousness and severity of the disease
Timepoint
Daily
Method of measurement
GCS , PACHE and SOFA Questionnaire
Intervention groups
1
Description
Intervention group: Patients in this group will receive a probiotic supplement for 14 days. The supplement is: a capsule containing seven types of probiotics (produced by Zist takhmir Company made in Iran) and consumed four times a day for 6 hours.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will receive a placebo for 14 days. Placebo contains starch (product of Zist takhmir Company made in Iran) and will be consumed four times a day for 6 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mehrangize Ebrahimi mamagani
Street address
خیابان گلگشت
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 7735
Fax
Email
dieterian.s.h.a@gamil.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. alireza ostad rahimi
Street address
خیابان گلگشت
City
Tbriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 7735
Email
nut-rc@tbzmed.ac.ir
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
Mehrangiz Ebrahimi Mamagani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 7735
Email
mebrahimimameghani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimi-Mameghani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
خیابان گلگشت، خیابان عطار نیشابوری، دانشکده تغذیه و علوم غذایی
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 7735
Email
ebrahimimamagani@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Hamze Abbaszadeh
Position
دانشجوی دکتری تخصصی تغذیه
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences., Attar Neyshaburi St., Golghast St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 7735
Email
abbaszadeh.h@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
Access starting 12 months after publication
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting meta-analysis.
From where data/document is obtainable
Mr. seyed hamze abbaszadeh- email: dieterian.s.h.a@gmail.com- Tel:00989128182987
What processes are involved for a request to access data/document
The applicant should provide a brief description of the aims and methods of his his Meta-analysis. His request will be assessed and, if agreed, the data will be emailed to the applicant. All these procedures will take no longer than 15 days.