The effect of seven-strain probiotic supplementation on T-helpers, inflammatory factors, and changes in nutritional status in patients with head trauma admitted to the intensive care unit: a randomized controlled clinical trial.

Abstract

Background: Severe Traumatic Brain Injury (TBI) refers to trauma or pressure resulting in damage to the head, leading to potential disruptions in brain function and symptoms of central nervous system impairment. The severity of TBI can range from mild to severe, resulting in significant cognitive and physiological disorders. Inflammatory processes are critical in the pathophysiology of Severe Traumatic Brain Injury. Probiotics can influence gut microbiota, modulate immune responses, and reduce inflammatory processes; however, their effectiveness in relation to inflammatory markers and T-helper (Th) cells in TBI patients has not been well established. This study aimed to evaluate the impact of probiotics on nutritional status, inflammatory markers, and Th cells in patients with Severe TBI. Methods: This double-blind, placebo-controlled clinical trial was conducted on 46 patients with severe brain injury due to trauma, with a Glasgow Coma Scale (GCS) score of less than 8. Patients were divided into two groups: probiotic and placebo. The probiotic group received four capsules containing beneficial Lactobacillus and Bifidobacterium strains, while the placebo group received four similar capsules without beneficial strains. The capsules were administered for 14 days via a nasogastric tube. Baseline and post-intervention data were collected on vital signs, dietary intake and tolerance, disease severity assessments, length of hospital stay, and mortality, including GCS, SOFA (Sequential Organ Failure Assessment), and APACHE II (Acute Physiology and Chronic Health Evaluation). Additionally, fasting blood samples (10 cc) were taken from patients at the beginning and end of the intervention to measure the frequency of T cells (Th17 and Treg) as well as serum levels of interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-α), transforming growth factor-beta (TGF-β), and interleukin-1 beta (IL-1β). Results: The results of our study showed that probiotic supplementation had significant positive effects on the immune and inflammatory status of patients with TBI. Based on the data obtained, probiotic supplementation reduced serum levels of (pg/ml) TNF-α (10.15 ± 2.65 to 6.05 ± 2.73) and IL-1β (pg/ml) (11.84 ± 4.77 to 8.77 ± 3.73) in the probiotic group compared to the placebo group at the end of the study, that was statistically significant (p< 0.001). Furthermore, the study results indicated that serum levels of anti-inflammatory cytokines (pg/ml) IL-10 (3.35 ± 1.54 to 7.17 ± 2.04) and (pg/ml) TGF-β (30.50 ± 12.25 to 46.25 ± 21.05) increased in the probiotic group compared to the placebo group at the end of the study, with this difference also being statistically significant (p< 0.001). Regarding the percentage of Th17 cells (as an effective factor in inflammatory responses) and Treg cells (as an effective factor in anti-inflammatory responses), the study results showed a decrease in Th17 cells at the end of the study in the probiotic group (5.19 ± 1.69 to 2.67 ± 1.09) and an increase in Treg cells (2.83 ± 1.03 to 4.29 ± 1.89), with significant statistical differences between the two groups (p< 0.001). In terms of disease severity assessed by GCS, the results indicated an improvement in GCS scores in the probiotic group compared to the placebo group at the end of the study (p< 0.001). However, no statistically significant differences in SOFA and APACHE II scores, as factors influencing length of stay and mortality, were observed between the two groups at the end of the study (p> 0.05). In terms of average energy and protein intake, improvements in dietary tolerance and intake, and vital sign variables, no statistically significant differences were observed between the probiotic and placebo groups at the end of the study (p > 0.05). Conclusion: The results of the present study indicate that probiotics can reduce inflammation and improve cellular immunity. If these findings are confirmed in future studies, probiotics may be considered as a supplementary treatment in patients with Severe TBI. Keywords: Probiotics, inflammatory factors, T lymphocytes, severe traumatic brain injury.