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NCT03865706 · ClinicalTrials.gov registry record · Phase 2
Inulin for Infections in the Intensive Care Unit
A Phase 2 study of Critical Illness and Sepsis, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
- 1
- Study location
NCT03865706: Completed Phase 2 study of Critical Illness and Sepsis, sponsored by Columbia University.
NCT03865706 is a Phase 2 study of Critical Illness and Sepsis that has completed, run by Columbia University. The registered enrollment target is 94 participants, below the 3,137-participant average among 91 other Critical Illness trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03865706, a Phase 2 study of Critical Illness and Sepsis, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Inulin Oral Suspension
- DRUG Placebo Oral Suspension
- DRUG Broad-spectrum antibiotics
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2019-10-14 |
| Est. Completion | 2024-07-23 |
| Phase | Phase 2 |
What the finished NCT03865706 record still lists
NCT03865706 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 3,137-participant average among 91 other Critical Illness trials with a reported enrollment target (97% lower).
The record links to 6 conditions, with Critical Illness appearing as the primary indexed condition, and to 3 interventions - of which Inulin Oral Suspension is the first listed.
NCT03865706 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03865706 about?
NCT03865706 is a clinical study titled "Inulin for Infections in the Intensive Care Unit". 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...
What is the current status of trial NCT03865706?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2019-10-14. Estimated completion is 2024-07-23.
What conditions does trial NCT03865706 study?
This clinical trial studies the following conditions: Critical Illness, Sepsis, Nutrition Disorders, Antibiotic Resistant Infection, Nosocomial Infection.
What interventions are being tested in trial NCT03865706?
The interventions under investigation include: Inulin Oral Suspension (DRUG), Placebo Oral Suspension (DRUG), Broad-spectrum antibiotics (DRUG).
Who is sponsoring clinical trial NCT03865706?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03865706 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03865706's enrollment target sits among peer trials
94 69th of 91 higher than 23 of 91 other Critical Illness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Illness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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