Effect of a seven-strain probiotic on dietary intake, inflammatory markers, and T-cells in severe traumatic brain injury patients: A randomized, double-blind, placebo-controlled trial
Abstract
Background Inflammatory processes are key factors in pathological events associated with severe traumatic brain injury (STBI). The aim of this trial was to determine the effect of probiotics on anthropometric measures, disease severity, inflammatory markers, and T cells in patients with STBI. Methods Forty adult patients with STBI were enrolled in this parallel randomized, double-blind, placebo-controlled trial. Energy and protein status, Acute Physiology and Chronic Health Evaluation (APACHE II) score, Sequential Organ Failure Assessment (SOFA), interleukin 10 (IL-10), interleukin 1β (IL-1β), tumor necrosis factor-alpha (TNF-α), transforming growth factor beta (TGF-β), T-helper 17 (Th17), and T- Regulator (T-reg) cells were assessed at baseline (day 1), and week 2 (day 14) for each patient. Results Probiotic supplementation led to a substantial reduction in the serum levels of TNF-α (from 10.15 ± 6.52 to 5.05 ± 3.27) (P = 0.034), IL-1β (from 11.84 ± 7.74 to 5.87 ± 3.77) (P < 0.001), and Th17 cells (from 5.19 ± 1.69 to 2.67 ± 1.89) (P < 0.001) and a substantial increase in the serum levels of IL-10 (from 3.35 ± 1.45 to 6.17 ± 2.04) (P = 0.038), TGF-β (from 30.5 ± 15.27 to 46.25 ± 21.05) (P < 0.001), and T-reg cells (from 2.83 ± 1.43 to 4.29 ± 1.89) (P < 0.001) compared with the placebo group. Furthermore, no notable changes were observed in energy and protein intake and also, terms of SOFA and APACHE II scores following probiotic treatment compared with the placebo.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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