Phase 2
N=94
Inulin for Infections in the Intensive Care Unit
Antibiotic Resistant Infection · Nosocomial Infection · Pathogen Transmission · Nutrition Disorders · Critical Illness
Bottom Line
View on ClinicalTrials.gov: NCT03865706 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Within-individual Change in SCFA Producer Level — -0.0; -1.8; 1.1 percentage of SCFA producers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Inulin Oral Suspension (Drug); Placebo Oral Suspension (Drug); Broad-spectrum antibiotics (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Within-individual Change in SCFA Producer Level |
-0.0; -1.8; 1.1 | — |
| SECONDARY Multidrug Resistant Organism (MDRO)-Gram Negative Bacteria (GNB) Colonization Status |
6; 4; 3; 3; 4; 3 | — |
| SECONDARY Vancomycin-resistant Enterococcus (VRE) Colonization Status |
8; 6; 4; 11; 13; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Hospitalized in an eligible medical ICU
- Age ≥ 18 years old at the time of hospitalization
- With sepsis as defined by the Sepsis-3 (2016) consensus as a known or suspected infection with a sequential organ failure assessment (SOFA) score of ≥2 points above baseline
- Received broad-spectrum antibiotics within the last 24 hours or ordered and pending administration
- Able to complete enrollment within 4 hours of ICU admission for administration of the intervention within 6 hours of ICU admission
Exclusion Criteria
- Inability to receive oral or enteric fluids
- Inulin allergy
- Hyponatremia (serum sodium ≤128 mEq/L)
- Immunosuppression, defined as history of solid organ transplant or as receipt of ablative chemotherapy, steroids at the equivalent of ≥5 mg/day prednisone, antimetabolites, anti-tumor necrosis factor (TNF) α agents, calcineurin inhibitors, or mycophenolate
- Surgery involving the intestinal lumen within 30 days or known intestinal strictures
- Do Not Resuscitate (DNR) or Do Not Intubate (DNI) status, or "no escalation of care" orders
- Lack capacity for consent and no appropriate Legally Authorized Representative (LAR)
Data sourced from ClinicalTrials.gov (NCT03865706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.