18 and older, any sex, with Antibiotic Resistant Infection or Nosocomial Infection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Within-individual Change in SCFA Producer LevelPrimary· Baseline and Day 3
Relative abundance (i.e., proportion) of SCFA producing bacteria within each treatment group, will be assessed via 16S sequencing of rectal swabs. Modified intent-to-treat, comparing baseline vs Day 3 levels of SCFAs among those who receive one or more doses of the intervention and complete both assessments.
Group
Value
95% CI
Placebo
-0.0
-7.9 – 7.4
Inulin 16 g/Day
-1.8
-8.9 – 3.7
Inulin 32 g/Day
1.1
-12 – 11
Multidrug Resistant Organism (MDRO)-Gram Negative Bacteria (GNB) Colonization StatusSecondary· Day 0 and at last sample collected, up to Day 30
Proportion of patients who are MDRO-GNB colonized within each treatment group, with MDRO-GNB colonization status classified categorically based on the presence or absence of methicillin-resistant Staphylococcus aureus (MRSA) or Gram negative bacteria (GNB) with third-generation cephalosporins non-susceptibility
Day 0
Group
Value
95% CI
Placebo
6
Inulin 16 g/Day
4
Inulin 32 g/Day
3
Last Sample Collected, Up to Day 30
Group
Value
95% CI
Placebo
3
Inulin 16 g/Day
4
Inulin 32 g/Day
3
Fecal Short Chain Fatty Acid (SCFA) LevelsSecondary· Days 3 and 7
The SCFAs butyrate, acetate, and propionate will be measured from whole stools on a 6490 triple quadrupole mass spectrometer and compared between intervention groups using the first stool sample produced after the Day 3 assessment. Patients who fail to produce a stool from Day 3 to 7 will be excluded from this analysis.
Day 3
Group
Value
95% CI
Placebo
0
0 – 0.18
Inulin 16 g/Day
0.11
0 – 0.66
Inulin 32 g/Day
0
0 – 0.46
Day 7
Group
Value
95% CI
Placebo
0
0 – 0.06
Inulin 16 g/Day
0.29
0 – 0.63
Inulin 32 g/Day
0
0 – 0.19
ICU Length of Stay (LOS)Secondary· through ICU Day 30
compared between groups, after adjusting for death as a competing risk
Group
Value
95% CI
Placebo
9.5
6 – 20
Inulin 16 g/Day
10.5
6 – 23
Inulin 32 g/Day
9
6 – 17
Multidrug Resistant (MDR) InfectionsSecondary· through 30 days
proportion of patients with culture-proven infections within each treatment group, with culture-proven infections defined as those that have (1) an organism meeting MDRO criteria from a clinical culture, (2) signs and symptoms of infection by Centers for Disease Control (CDC)/National Health and Safety Network (NHSN) guideline definitions, and (3) receive appropriate antibiotics from the treating team
Group
Value
95% CI
Placebo
15
Inulin 16 g/Day
9
Inulin 32 g/Day
12
MortalitySecondary· Day 90
Death data will be extracted from the hospital electronic medical record (EMR) which immediately captures in-hospital death and receives monthly mortality updates from the National social security death index.
Group
Value
95% CI
Placebo
7
Inulin 16 g/Day
7
Inulin 32 g/Day
9
Vancomycin-resistant Enterococcus (VRE) Colonization StatusSecondary· Day 0 and at last sample collected, up to Day 30
Proportion of patients who are VRE colonized within each treatment group, with VRE colonization status classified categorically based on the presence or absence of vancomycin-resistant Enterococcus (VRE)
Day 0
Group
Value
95% CI
Placebo
8
Inulin 16 g/Day
6
Inulin 32 g/Day
4
Last Sample Collected, Up to Day 30
Group
Value
95% CI
Placebo
11
Inulin 16 g/Day
13
Inulin 32 g/Day
6
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Day 90.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Columbia University
Last refreshed: 19 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03865706.