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Early and sustained Lactobacillus plantarum probiotic therapy in critical illness: the randomised, placebo-controlled, restoration of gut microflora in critical illness trial (ROCIT)

  • 2021-02-10
  • Intensive Care Medicine 47(3)
    • E. Litton
    • M. Anstey
    • David I. Broadhurst
    • A. Chapman
    • A. Currie
    • J. Ferrier
    • J. Gummer
    • A. Higgins
    • Jolene Lim
    • L. Manning
    • E. Myers
    • Katrina Orr
    • Anne-Marie Palermo
    • A. Paparini
    • S. Pellicano
    • E. Raby
    • A. Rammohan
    • A. Regli
    • Bernhard Richter
    • S. Salman
    • T. Strunk
    • S. Waterson
    • D. Weight
    • B. Wibrow
    • F. Wood

Abstract

Purpose: In adults requiring treatment in an intensive care unit, probiotic therapy using Lactobacillus plantarum 299v may reduce nosocomial infection. The aim of this study was to determine whether early and sustained L. plantarum 299v therapy administered to adult ICU patients increased days alive and at home.

Methods: A multicentre, parallel group, placebo-controlled, randomised clinical trial was conducted. Adult patients within 48 h of intensive care admission and expected to require intensive care beyond the day after recruitment were eligible to participate. L plantarum 299v or placebo were administered immediately after enrolment and continued for 60 days. The primary outcome was days alive and out of hospital to Day 60 (DAOH60). Secondary outcomes included nosocomial infections.

Results: The median [interquartile range (IQR)] number of DAOH60 in the probiotic (n = 110) and placebo group (n = 108) was 49.5 (IQR 37.0-53.0) and 49.0 (IQR 43.8-53.0) respectively, between-group difference of 0.0 [95% confidence interval (CI) - 6.10 to 7.1, P = 0.55]. Nosocomial infection occurred in 8 (7.3%) and 5 (4.6%) of the probiotic and placebo group participants, respectively, odds ratio 1.62 (95% CI 0.51-5.10), P = 0.57. There were no serious, or probiotic-associated adverse events.

Conclusion: Early and sustained untargeted administration of probiotic therapy with Lactobacillus plantarum 299v to adult patients admitted to the ICU is safe, but not associated with improved patient outcomes.

Keywords: Critical illness; Intensive care unit; Nosocomial infection; Probiotics.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Lactobacillus Bulgaricus & Lactobacillus PlantarumReduced MortalityNeutral
Small
Lactobacillus Bulgaricus & Lactobacillus PlantarumReduced Nosocomial Infection RateNeutral
Small
Lactobacillus plantarumReduced Nosocomial InfectionsNeutral
Small
Lactobacillus plantarum DR7Reduced Nosocomial InfectionsNeutral
Small
Lactobacillus plantarum DSM 6595Adverse Events from ProbioticsNeutral
Small
Lactobacillus plantarum DSM 6595Reduced Nosocomial InfectionsNeutral
Small
Lactobacillus plantarum DSM 6596Reduced Nosocomial InfectionsNeutral
Small
Lactobacillus plantarum HA-119Improved Overall Patient OutcomesNeutral
Small
Lactobacillus plantarum HA-119Reduced Nosocomial Infection RateNeutral
Small
Lactobacillus plantarum LP-01Reduced Nosocomial InfectionsNeutral
Small
Lactobacillus plantarum LP09Reduced Nosocomial InfectionsNeutral
Small
Lactobacillus plantarum Lp-115Reduced Nosocomial InfectionsNeutral
Small
Lactobacillus plantarum N13Improved Survival RateNeutral
Small
Lactobacillus plantarum N13Increased Adverse EventsNeutral
Small
Lactobacillus plantarum R1012Reduced Nosocomial InfectionsNeutral
Small
Lactobacillus plantarum Rosell-1012Reduced Nosocomial InfectionsNeutral
Small
Lactobacillus plantarum Rosell-AReduced Nosocomial Infection IncidenceNeutral
Small
Lactobacillus plantarum SD5209Reduced Nosocomial InfectionsNeutral
Small
Lactobacillus plantarum SD-5209Reduced Nosocomial Infection RateNeutral
Small
Lactobacillus plantarum UALp-05MReduced Nosocomial InfectionsNeutral
Small
Lactobacillus plantarum VPro 10Reduced Nosocomial InfectionsNeutral
Small

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