The effect of seven-stroke probiotic supplementation on some of the Thelpers, oxidative balance ICAM, VCAM, 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, oxidative balance ICAM, VCAM, inflammatory factors and changes in nutritional status in patients with head trauma, admitted to intensive care unit

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.

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.

- 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

A 40 patients with traumatic brain injury who have GCS below 8, will be fed nasopharyngeal tube and connected to a ventilator

Th-17; T-regulatory; Th10; TGF-β; IL-6, ICAM; VCAM IL-1β; length of hospital stay; Damping rate; Respiratory tract infection; Weight ; Height; Body mass index; (BMI) tolerance and improvement of nutritional status; energy and macro nutrients intake ; level of consciousness ; Illness severity

Addition of factors related to oxidative stress ICAM and VCAM

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.

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.

Data collected for the primary outcomes will be shared.

Access starting 12 months after publication

The data will only be available for people working in academic institutions.

The data of the present study will only be accessible by other researchers, for conducting meta-analysis.

Mr. seyed hamze abbaszadeh- email: dieterian.s.h.a@gmail.com- Tel:00989128182987

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.