The effect of probiotic and synbiotic supplementation on clinical, prognostic, and biochemical indicators in patients with traumatic brain injury
Design
The design of this study is a parallel clinical trial in phase 3. It has a control group and patients will be assigned to study groups using a blocked randomization method. Blinding is double-blind and the sample size is 105 patients.
Settings and conduct
The aim of this study is to determine the effect of probiotic and synbiotic supplementation on clinical, prognostic, and biochemical outcomes of patients with traumatic brain injury admitted to Shohada Haftom Tir Hospital, Ray, affiliated with Iran University of Medical Sciences. Both patients and outcome assessors will be unaware of the type of intervention received by study participants, which ultimately results in double-blind blinding.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study were diagnosis of traumatic brain injury by CT scan and diagnosis by a specialist physician; age 18 to 70 years; hemodynamic stability of the patient. The exclusion criteria were pregnancy or breastfeeding and use of probiotic or synbiotic supplements in the last month before the start of the study.
Intervention groups
In this study, we have three groups: the first group receives a probiotic supplement, the second group receives a synbiotic supplement, and the third group receives a placebo.
Main outcome variables
Mortality; Number of days in hospital; C-reactive protein; Interleukin 6; Interleukin 10; Glasgow Coma Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250125064510N2
Registration date:2025-04-18, 1404/01/29
Registration timing:prospective
Last update:2025-04-18, 1404/01/29
Update count:0
Registration date
2025-04-18, 1404/01/29
Registrant information
Name
Seyed Mohammad Aghaeinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 86701
Email address
aghaeinejad.m@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2025-10-22, 1404/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Surveying of the Effect of Probiotic and Synbiotic Supplementation in Patients with Traumatic Brain Injury.
Public title
The effect of probiotics and synbiotics in brain trauma.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of brain trauma with CT scan and diagnosis by a specialist
Diagnosis of severe brain trauma with a Glasgow Coma Scale between 3 and 8
Age 18 to 70 years
Need for at least ten days of hospitalization in the intensive care unit with the diagnosis and prognosis of the relevant specialist
Patient's hemodynamic stability
Exclusion criteria:
Pregnancy or lactation
Previous major gastrointestinal; hematological; endocrine diseases; Immunosuppression; Pneumonia or other infectious diseases after admission; HIV positivity; cancer
Use of probiotic or synbiotic supplements within the last month prior to study entry
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method was used in this study. The size of
the blocks is considered to be six and will be selected randomly so that it is
not predictable to the participants based on the blocks. First, we will
receive using Random Allocation software and by determining the sample
size, the number of groups, the type of randomization and is random the
order of the blocks in the software output and will be shown in the software
output of groups with letters A, B and C. Then, after selecting each patient
based on the inclusion and non-inclusion criteria, the project manager will
be informed and he will tell the type of intervention of that patient based on
the order of inclusion of patients and compliance with the number
mentioned in the randomization output.
Blinding (investigator's opinion)
Double blinded
Blinding description
We will inform the supervisor after selecting each patient for the study
and they are based on the randomized output of the randomization
software and its matching to the patient's number the interventions will be
sent in a form that is not known to the patients, prescriptive, and evaluator
of the outcomes. Blinding process in this study is double blinded.
Participants in the study will be blinded of interventions also the physicians
will be blinded of the type of interventions received by the participants
when they evaluated the outcome.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2025-03-03, 1403/12/13
Ethics committee reference number
IR.IUMS.REC.1403.1123
Health conditions studied
1
Description of health condition studied
Trauma brain injury
ICD-10 code
S06.2X
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
C-reactive protein
Timepoint
Beginning of the study and the tenth day of the study
Method of measurement
Enzyme-linked immunosorbent assay
2
Description
Interleukin 6
Timepoint
Beginning of the study and the tenth day of the study
Method of measurement
Enzyme-linked immunosorbent assay
Secondary outcomes
1
Description
Erythrocyte sedimentation rate
Timepoint
Beginning of the study and the tenth day of the study
Method of measurement
Westergren
2
Description
Assessing the level of consciousness
Timepoint
Beginning of the study and the tenth day of the study
Method of measurement
Glasgow Coma Scale
3
Description
Disease severity score
Timepoint
Beginning of the study and the tenth day of the study
Method of measurement
Acute Physiology and Chronic Health Evaluation II (APACHE II)
4
Description
Organ failure in the intensive care unit
Timepoint
Beginning of the study and the tenth day of the study
Method of measurement
Sequential Organ Failure Assessment score (SOFA score)
5
Description
Length of hospital stay
Timepoint
Study start and discharge time
Method of measurement
Patient file
6
Description
Mortality
Timepoint
30 days after receiving interventions
Method of measurement
The discharge status of the patient as well as telephone follow-up 28days after receiving the intervention
Intervention groups
1
Description
Intervention group: The first intervention group received a probiotic supplement containing 1×109 CFU of probiotic organisms for 10 days from Tekgen Zist Company.
Category
Treatment - Other
2
Description
Intervention group: The second intervention group received a synbiotic supplement (containing 1×109 CFU of probiotic organisms and fructo-oligosaccharide) for 10 days from Tekgen Zist Company.
Category
Treatment - Other
3
Description
Control group: Receiving a placebo that has a similar appearance to the two intervention groups and contains cellulose for ten days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye haftome tir hospital
Full name of responsible person
Seyed Mohammad Adhaeinejad
Street address
end of Shahid Rajaee South Street, Shahr-e Ray, Tehran
City
Tehran
Province
Tehran
Postal code
1886718136
Phone
+98 21 5522 8580
Email
m.aqaei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Safa
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
safa.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Aghaeinejad
Position
Research Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
0098 21 64351
Email
m.aqaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Aghaeinejad
Position
Research Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2255
Email
m.aqaei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Aghaeinejad
Position
Research Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2255
Email
m.aqaei@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
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
Yes - There is 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
Title and more details about the data/document
Finding of the study, demographic data of participants in the study, in
addition to descriptive and analytical analysis of variables.
When the data will become available and for how long
Availability 9 months after the end of study
To whom data/document is available
Nutritionists and experts, anesthesiologists, nurses, intensive care fellowship
Under which criteria data/document could be used
Requests may be made by organizations, journals or project supervisors. These requests will be read by the research team under the supervision of a university representative, and if the requests are reasonable, relevant de-identified data will be sent. This request may be some results of biomarkers or codes performed for data analysis.
From where data/document is obtainable
The initial request can be sent to the email of the people who are in the scientific and general response section of the trial (m.aqaei@yahoo.com). Applicants can also refer to the Research Vice-Chancellor of Iran University of Medical Sciences located on Hemet Highway or the Iran Clinical Trial Center located in the Central Library of Iran University of Medical Sciences.
What processes are involved for a request to access data/document
After the institution agrees to send data for requests, depending on whether the requester is inside the country or abroad, and also according to the type of requested data, the time to respond to the requests will be different. Finally, no request will take more than one month.