Inulin for Infections in the Intensive Care Unit

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2024-07-23

Brief Summary

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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.

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Detailed Description

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The proposed trial hypothesizes that inulin maintains short-chain fatty acid (SCFA)-producing colonic anaerobes and that these bacteria are protective against multi-drug resistant organism (MDRO) colonization and subsequent MDR infection. Inulin, a vegetable-derived non-digestible polysaccharide is well established as the key nutrient source for SCFA-producing bacteria. Previous human studies have shown that (1) inulin increases levels of SCFA producers and SCFAs and (2) that this increase correlates with improved colonic mucosal integrity and resistance to MDR pathogens. In animal studies, inulin improves survival after pathogen challenge or injection with lipopolysaccharide. The overall aim of this clinical trial is to determine whether inulin improves gut colonization resistance against antibiotic-resistant pathogens and therefore prevents antibiotic-resistant infections in the setting of critical illness. To accomplish this, 90 critically ill adults who are receiving broad-spectrum antibiotics will be blindly randomized 1:1:1 to receive placebo, inulin 8 g twice daily, or inulin 16 g twice daily for a minimum of 7 days, with bedside follow-up extending to 30 days or hospital discharge.

Conditions

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Antibiotic Resistant Infection Nosocomial Infection Pathogen Transmission Nutrition Disorders Critical Illness Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

placebo-controlled trial with 1:1:1 enrollment into three arms: inulin 32 g/day, inulin 16 g/day, and placebo

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double-blind, randomized

Study Groups

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Inulin 32 g/day

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 Type EXPERIMENTAL

Inulin Oral Suspension

Intervention Type DRUG

Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube

Broad-spectrum antibiotics

Intervention Type DRUG

Standard of care treatment for infections

Inulin 16 g/day

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 Type EXPERIMENTAL

Inulin Oral Suspension

Intervention Type DRUG

Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube

Broad-spectrum antibiotics

Intervention Type DRUG

Standard of care treatment for infections

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Suspension

Intervention Type DRUG

250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor

Broad-spectrum antibiotics

Intervention Type DRUG

Standard of care treatment for infections

Interventions

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Inulin Oral Suspension

Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube

Intervention Type DRUG

Placebo Oral Suspension

250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor

Intervention Type DRUG

Broad-spectrum antibiotics

Standard of care treatment for infections

Intervention Type DRUG

Other Intervention Names

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Inulin Placebo Antibiotics

Eligibility Criteria

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Inclusion Criteria

1. Hospitalized in an eligible medical ICU
2. Age ≥ 18 years old at the time of hospitalization
3. With sepsis as defined by the Sepsis-3 (2016) consensus as a known or suspected infection with a sequential organ failure assessment (SOFA) score of ≥2 points above baseline
4. Received broad-spectrum antibiotics within the last 24 hours or ordered and pending administration
5. Able to complete enrollment within 4 hours of ICU admission for administration of the intervention within 6 hours of ICU admission

Exclusion Criteria

1. Inability to receive oral or enteric fluids
2. Inulin allergy
3. Hyponatremia (serum sodium ≤128 mEq/L)
4. 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-tumor necrosis factor (TNF) α agents, calcineurin inhibitors, or mycophenolate
5. Surgery involving the intestinal lumen within 30 days or known intestinal strictures
6. Do Not Resuscitate (DNR) or Do Not Intubate (DNI) status, or "no escalation of care" orders
7. Lack capacity for consent and no appropriate Legally Authorized Representative (LAR)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No