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Prebiotic Fiber

Inulin for ICU Infections

Phase 2

Waitlist Available

Led By Daniel E Freedberg, MD, MS

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years old at the time of hospitalization

Received broad-spectrum antibiotics within the last 24 hours or ordered and pending administration

Must not have

Inability to receive oral or enteric fluids

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-TNFα agents, calcineurin inhibitors, or mycophenolate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through day 3 and through day 7

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial will test whether inulin is safe and may help to prevent antibiotic resistant infections in the ICU.

Who is the study for?

This trial is for adults over 18 in the ICU with sepsis who've recently started antibiotics. It's not for those allergic to inulin, with very low sodium levels, weakened immune systems from certain treatments or conditions, recent gut surgery, strict 'do not resuscitate' orders, or unable to consent without a legal rep.

What is being tested?

The study tests if inulin (a prebiotic fiber) can prevent antibiotic-resistant infections by improving gut health in critically ill patients. Participants will either receive an inulin oral suspension or a placebo while being monitored for safety and effectiveness against resistant pathogens.

What are the potential side effects?

While specific side effects of inulin are not detailed here, it may include digestive discomfort like bloating or gas. The trial aims to assess its tolerability and safety among ICU patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have taken broad-spectrum antibiotics in the last 24 hours.

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I am currently admitted in a medical ICU that is part of the study.

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I have sepsis with a significant increase in my SOFA score.

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I can start the study within 4 hours of being admitted to the ICU.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take in fluids by mouth or through the gut.

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I am immunosuppressed due to a solid organ transplant or specific medications.

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I cannot give consent and have no one legally allowed to do so for me.

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I have had recent intestinal surgery or have narrowings in my intestines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through day 3 and through day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through day 3 and through day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 3 and through day 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MDR infections

MDRO colonization status

Within-individual change in SCFA producer level

Secondary study objectives

ICU length of stay (LOS)

Multi-omic approach to changes related to inulin

Nutritional intake

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Inulin 32 g/dayExperimental Treatment2 Interventions

Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.

Group II: Inulin 16 g/dayExperimental Treatment2 Interventions

Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.

Group III: PlaceboPlacebo Group2 Interventions

Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inulin

FDA approved

Broad-spectrum antibiotics

2019