drugset / Trial / NCT03865706

Inulin for Infections in the Intensive Care Unit

NCT03865706

Phase 2 Completed 94 enrolled Columbia University
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Normal gut bacteria prevent colonization and subsequent infection with MDR organisms (MDROs) through competition for resources and other mechanisms. During critical illness, this function of the microbiome is lost and there are no current treatments to restore it. Preliminary data indicates that the prebiotic fiber inulin is safe and may alter the gastrointestinal microbiome to improve gut barrier function, decrease colonization with MDROs, and reduce downstream risk for intensive care unit (ICU)-acquired MDR infections. However, the impact of inulin during critical illness is unknown. This double-blind, randomized clinical trial will test inulin for the prevention of antibiotic resistant infections in the ICU. The trial's specific aims are to determine (1) the feasibility, tolerability, and safety of inulin in the intensive care unit; (2) the impact of inulin on gut colonization with antibiotic-resistant pathogens; and (2A/exploratory) the impact of inulin on ICU-acquired antibiotic-resistant infections.

Timeline

Start
2019-10-14
Primary completion
2023-11-21
Completion
2024-07-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Inulin Other / unclassified 8 g Oral
Subject Inulin Other / unclassified 16 g Oral