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Inulin for Infections in the Intensive Care Unit

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Columbia University

Status and phase

Completed
Phase 2

Conditions

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

Treatments

Drug: Inulin Oral Suspension
Drug: Placebo Oral Suspension
Drug: Broad-spectrum antibiotics

Study type

Interventional

Funder types

Other

Identifiers

NCT03865706
PR181960 (Other Grant/Funding Number)
AAAS2576

Details and patient eligibility

About

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.

Full description

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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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-TNFα 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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 3 patient groups, including a placebo group

Inulin 32 g/day
Experimental group
Description:
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.
Treatment:
Drug: Broad-spectrum antibiotics
Drug: Inulin Oral Suspension
Inulin 16 g/day
Experimental group
Description:
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.
Treatment:
Drug: Broad-spectrum antibiotics
Drug: Inulin Oral Suspension
Placebo
Placebo Comparator group
Description:
Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.
Treatment:
Drug: Broad-spectrum antibiotics
Drug: Placebo Oral Suspension

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Daniel E Freedberg, MD, MS; Elissa Lynch

Data sourced from clinicaltrials.gov

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