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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
Age ≥ 18 years old at the time of hospitalization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 3 and through day 7
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 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.
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I have sepsis with a significant increase in my SOFA score.
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I am currently admitted in a medical ICU that is part of the study.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MDR infections
MDRO colonization status
Within-individual change in SCFA producer level
Secondary outcome measures
ICU length of stay (LOS)
Multi-omic approach to changes related to inulin
Nutritional intake

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
Broad-spectrum antibiotics
2014
N/A
~2480

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,424 Previous Clinical Trials
2,472,937 Total Patients Enrolled
Daniel E Freedberg, MD, MSPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
7 Total Patients Enrolled

Media Library

Inulin (Prebiotic Fiber) Clinical Trial Eligibility Overview. Trial Name: NCT03865706 — Phase 2
Antibiotic Resistance Research Study Groups: Placebo, Inulin 32 g/day, Inulin 16 g/day
Antibiotic Resistance Clinical Trial 2023: Inulin Highlights & Side Effects. Trial Name: NCT03865706 — Phase 2
Inulin (Prebiotic Fiber) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03865706 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the consumption of broad-spectrum antibiotics sanctioned by the FDA?

"The safety of Broad-spectrum antibiotics is rated as a 2 due to the available evidence that suggests its safety, however there has yet to be sufficient data demonstrating efficacy."

Answered by AI

Are there any available spots to join this medical investigation?

"Clinicaltrials.gov is currently advertising this medical trial, which was first uploaded on October 14th 2019 and has been recently revised as of October 11th 2022."

Answered by AI

What other studies have been done to assess the efficacy of broad-spectrum antibiotics?

"Presently, there are two medical investigations into Broad-spectrum antibiotics that haven't yet reached their final stage. Both studies emanate from Changsha in Hunan and have advanced to Phase 2."

Answered by AI

To what extent are participants being treated in this trial?

"Affirmative. According to clinicaltrials.gov, this study is still in progress and accepting participants since its inception on October 14th 2019 as of the most recent update on October 11th 2022. Ninety individuals are needed across a single site for enrollment purposes."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Apr 2024