A phase 2 randomized, placebo-controlled trial of inulin for the prevention of gut pathogen colonization and infection among patients admitted to the intensive care unit for sepsis
Authors' conclusion
Prebiotic fiber had minimal impact on the gut microbiome in the ICU and did not improve clinical outcomes.
Study context
- Population
- Adults admitted to the medical intensive care unit (ICU) for sepsis receiving broad-spectrum antibioticsanalysed
- Participants
- 90 adults
- Comparison
- Inulin 16 g/day or 32 g/day vs placebo for 7 days
- Placebon = 30reference
- Inulin 16 g/dayn = 30
- Inulin 32 g/dayn = 30
- Primary endpoint
- Within-individual change in relative abundance of short chain fatty acid (SCFA)-producing bacteria on rectal swabs (surrogate for gut colonization resistance)
- Follow-up
- ICU admission to Day 3
Methodological detailsdouble-blind, placebo-controlled, phase two, 1:1:1 randomisation
- Double-blind
- Placebo-controlled
- Phase two
- 1:1:1 randomisation
Primary result
As reported in the abstract
P = 0.91
Further findings
Short chain fatty acid (SCFA)-producer levels, microbiome diversity, gut pathogen colonization · ICU Day 7 (end of treatment)
- Not affected by inulin
Death or clinical, culture-proven infection · 30 days
- Not affected by inulin
SCFA-producer abundance at ICU admission in patients who died or developed culture-proven infection vs those who did not
- Lower in patients who died or developed culture-proven infection
- P = 0.03
Original publication
A phase 2 randomized, placebo-controlled trial of inulin for the prevention of gut pathogen colonization and infection among patients admitted to the intensive care unit for sepsis. Crit Care. Published 13 January 2025. doi:10.
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