Evidence map›Paper›PMID 39806400›Full record

Trial reportCritical care (London, England)2025

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.

Heekuk Park, Elissa Lynch, Alice Tillman, Kristen Lewis, Zhezhen Jin, Anne-Catrin Uhlemann, Julian A Abrams, Daniel E Freedberg

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Critical care (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03865706 (Prebiotic Inulin to Limit Antimicrobial-Resistant Infections During Critical Illness), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03865706 phase2completednot on this map

Prebiotic Inulin to Limit Antimicrobial-Resistant Infections During Critical Illness: A Phase II Clinical Trial

TypeinterventionalSponsorColumbia UniversityRan2019 to 2024Enrolled94ConditionsAntibiotic Resistant Infection, Nosocomial Infection, Pathogen Transmission, Nutrition DisordersArmsInulin Oral Suspension, Placebo Oral Suspension, Broad-spectrum antibiotics
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Can We Identify Severe Dysbiosis at the Bedside?Critical care explorations · 2026
    Article
  4. Review
  5. The gastrointestinal microbiome in critical illness: A Clinician's guide to mechanisms, emerging tools, and therapeutic questions.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2025
    Review
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Heekuk ParkDivision of Infectious Diseases & Microbiome Core Facility, Columbia University Irving Medical Center, 630 West 168th Street, PS 9-428, New York, NY, 10032, USA.
Elissa LynchDivision of Digestive and Liver Diseases, Columbia University Irving Medical Center, 630 West 168th Street, P&S 3-401, New York, NY, 10032, USA.
Alice TillmanDivision of Infectious Diseases & Microbiome Core Facility, Columbia University Irving Medical Center, 630 West 168th Street, PS 9-428, New York, NY, 10032, USA.
Kristen LewisDivision of Infectious Diseases & Microbiome Core Facility, Columbia University Irving Medical Center, 630 West 168th Street, PS 9-428, New York, NY, 10032, USA.
Zhezhen JinMailman School of Public Health, Columbia University, 722 W 168th St, New York, NY, 10032, USA.
Anne-Catrin UhlemannDivision of Infectious Diseases & Microbiome Core Facility, Columbia University Irving Medical Center, 630 West 168th Street, PS 9-428, New York, NY, 10032, USA.
Julian A AbramsDivision of Digestive and Liver Diseases, Columbia University Irving Medical Center, 630 West 168th Street, P&S 3-401, New York, NY, 10032, USA.
Daniel E FreedbergDivision of Digestive and Liver Diseases, Columbia University Irving Medical Center, 630 West 168th Street, P&S 3-401, New York, NY, 10032, USA. def2004@cumc.columbia.edu.

Funding

The Organoid and Cell Culture CoreP30DK132710 · NIDDK · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI Jianwen Que · 2022 to 2026
$7.2M
Columbia Division of Digestive and Liver Disease P30DK132710Department of Defense Peer Reviewed Medical Research Program PR181960NIDDK NIH HHS P30 DK132710
6 · The paper itself

Abstract

backgroundPatients admitted to the intensive care unit (ICU) often have gut colonization with pathogenic bacteria and such colonization is associated with increased risk for death and infection. We conducted a trial to determine whether a prebiotic would improve the gut microbiome to decrease gut pathogen colonization and decrease downstream risk for infection among newly admitted medical ICU patients with sepsis.

methodsThis was a randomized, double-blind, placebo-controlled trial of adults who were admitted to the medical ICU for sepsis and were receiving broad-spectrum antibiotics. Participants were randomized 1:1:1 to placebo, inulin 16 g/day, or inulin 32 g/day which were given for seven days. The trial primary outcome was a surrogate measure for gut colonization resistance, namely the within-individual change from ICU admission to Day 3 in the relative abundance of short chain fatty acid (SCFA)-producing bacteria based on rectal swabs. Additional outcomes sought to evaluate the impact of inulin on the gut microbiome and downstream clinical effects.

resultsNinety participants were analyzed including 30 in each study group. There was no difference between study groups in the within-individual change in the relative abundance of SCFA-producing bacteria from ICU admission to ICU Day 3 (placebo: 0.0% change, IQR - 8·0% to + 7·4% vs. combined inulin: 0·0% change, IQR - 10·1% to + 4·8%; p = 0·91). At end-of-treatment on ICU Day 7, inulin did not affect SCFA-producer levels, microbiome diversity, or rates of gut colonization with pathogenic bacteria. After 30 days of clinical follow-up, inulin did not affect rates of death or clinical, culture-proven infection. Patients who died or developed culture-proven infections had lower relative abundance of SCFA-producing bacteria at ICU admission compared to those who did not (p = 0·03).

conclusionsPrebiotic fiber had minimal impact on the gut microbiome in the ICU and did not improve clinical outcomes.

trial registrationClinicaltrials.gov: NCT03865706.

Indexed as

Anti-Bacterial AgentsGastrointestinal MicrobiomeInulinPrebioticsSepsisAdultAgedDouble-Blind MethodFemaleHumansIntensive Care UnitsMaleMiddle AgedAnti-Bacterial AgentsInulinPrebiotics

Identifiers

PMID39806400
PMCPMC11731134

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.