Trial reportCritical care (London, England)2011
Effects of probiotics on serum levels of Th1/Th2 cytokine and clinical outcomes in severe traumatic brain-injured patients: a prospective randomized pilot study.
Trial report in Critical care (London, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 97 papers, 16 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
97 citing papers in PubMed, 16 syntheses or guidelines pooled it, 171 citations in OpenAlex.
- Targeting the gut to heal the skin: probiotic supplementation reduces wound infection risk and clinical burden in critically ill patients-a systematic review and meta-analysis.Frontiers in nutrition · 2026Pooled it
- Role of probiotic supplementation in preventing ventilator-associated pneumonia among critically ill patients-a critical umbrella review of meta-analyses of randomized controlled trials.Frontiers in nutrition · 2025Pooled it
- Probiotic-based therapy as a new useful strategy for the treatment of patients with traumatic brain injury.BMC infectious diseases · 2024Pooled it
- The safety and efficacy of probiotic supplementation for critically ill adult patients: a systematic review and meta-analysis.Nutrition reviews · 2023Pooled it
- Probiotics improve symptoms of patients with COVID-19 through gut-lung axis: a systematic review and meta-analysis.Frontiers in nutrition · 2023Pooled it
- Probiotic in the prevention of ventilator-associated pneumonia in critically ill patients: evidence from meta-analysis and trial sequential analysis of randomized clinical trials.BMC pulmonary medicine · 2022Pooled it
- Pooled it
- Probiotic Supplementation Prevents the Development of Ventilator-Associated Pneumonia for Mechanically Ventilated ICU Patients: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.Frontiers in nutrition · 2022Pooled it
- Synbiotic Therapy Prevents Nosocomial Infection in Critically Ill Adult Patients: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials Based on a Bayesian Framework.Frontiers in medicine · 2021Pooled it
- Clinical Benefits From Administering Probiotics to Mechanical Ventilated Patients in Intensive Care Unit: A PRISMA-Guided Meta-Analysis.Frontiers in nutrition · 2021Pooled it
- Pooled it
- Impact of Probiotic Administration on Serum C-Reactive Protein Concentrations: Systematic Review and Meta-Analysis of Randomized Control Trials.Nutrients · 2017Pooled it
- Probiotic and synbiotic therapy in critical illness: a systematic review and meta-analysis.Critical care (London, England) · 2016Pooled it
- Probiotics for preventing ventilator-associated pneumonia.The Cochrane database of systematic reviews · 2014Pooled it
- Use of probiotics in the treatment of severe acute pancreatitis: a systematic review and meta-analysis of randomized controlled trials.Critical care (London, England) · 2014Pooled it
- Probiotics' effects on the incidence of nosocomial pneumonia in critically ill patients: a systematic review and meta-analysis.Critical care (London, England) · 2012Pooled it
- Effect of probiotics on intestinal permeability in critically ill children with sepsis: preliminary results from a double-blind, placebo-controlled trial.European journal of nutrition · 2025Trial
- Effects of probiotics combined with early enteral nutrition on endothelin-1 and C-reactive protein levels and prognosis in patients with severe traumatic brain injury.The Journal of international medical research · 2020Trial
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37 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTraumatic brain injury (TBI) is associated with a profound immunological dysfunction manifested by a severe shift from T-helper type 1 (Th1) to T-helper type 2 (Th2) response. This predisposes patients to infections, sepsis, and adverse outcomes. Probiotic bacteria have been shown to balance the Th1/Th2 cytokines in allergic murine models and patients. For the present study, we hypothesized that the enteral administration of probiotics would adjust the Th1/Th2 imbalance and improve clinical outcomes in TBI patients.
methodsWe designed a prospective, randomized, single-blind study. Patients with severe TBI and Glasgow Coma Scale scores between 5 and 8 were included, resulting in 26 patients in the control group and 26 patients in the probiotic group. All patients received enteral nutrition via a nasogastric tube within 24 to 48 hours following admission. In addition, the probiotic group received 109 bacteria of viable probiotics per day for 21 days. The associated serum levels of Th1/Th2 cytokines, Acute Physiology and Chronic Health Evaluation (APACHE) II and Sequential Organ Failure Assessment (SOFA) scores, nosocomial infections, length of ICU stay, and 28-day mortality rate were studied.
resultsThe patients responded to viable probiotics, and showed a significantly higher increase in serum IL-12p70 and IFNγ levels while also experiencing a dramatic decrease in IL-4 and IL-10 concentrations. APACHE II and SOFA scores were not significantly affected by probiotic treatment. Patients in the probiotic group experienced a decreased incidence of nosocomial infections towards the end of the study. Shorter ICU stays were also observed among patients treated with probiotic therapy. However, the 28-day mortality rate was unaffected.
conclusionsThe present study showed that daily prophylactic administration of probiotics could attenuate the deviated Th1/Th2 response induced by severe TBI, and could result in a decreased nosocomial infection rate, especially in the late period.
trial registrationChiCTR-TRC-10000835.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.