Prebiotic Fiber to Prevent Pathogen Colonization in the ICU

NCT03509753 | Completed

• 2 other identifiers: AAAR51621K23DK111847-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot trial testing enteral feeds that are high versus low in prebiotic fiber in 20 critically ill adults. The long-term goal is to determine the efficacy of fiber for the prevention of pathogen colonization/infection in the ICU.

Conditions

Sepsis

Keywords

Prebiotic fiber

Outcome Measures

Primary Outcomes (1)

• Change in microbiome measured by LEfSe

  An untargeted hierarchical linear discriminant analysis effect size algorithm (LEfSe) will be used to test for within-individual taxonomic differences comparing baseline to Day 3 in the high fiber group as it is an established method for identifying differences in bacterial taxa between any two groups. For those taxa which are significantly altered on LEfSe, the relative change in the high fiber group versus the relative change in the low fiber group will be computed using a rank-sum test.

  Baseline and Day 3

Study Arms (2)

High Fiber

EXPERIMENTAL

Per 10 ounces of feed: 4 g oat-soy fiber with 45% short-chain fructooligosaccharides, 296 kCal, 19 g protein, 8 g fat, and 39 g carbohydrates. Feed rate/duration individualized for each patient.

Dietary Supplement: High Fiber

Low Fiber

ACTIVE COMPARATOR

Per 10 ounces of feed: 0 g fiber, 296 kCal, 19 g protein, 8 g fat, and 39 g carbohydrates. Feed rate/duration individualized for each patient.

Dietary Supplement: Low Fiber

Interventions

High Fiber DIETARY_SUPPLEMENT

See intervention description.

High Fiber

Low Fiber DIETARY_SUPPLEMENT

See intervention description.

Low Fiber

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical or surgical ICU patients ≥18 years old at our institution;
• Receiving broad-spectrum antibiotics at the time of enrollment;
• Deemed appropriate for the study by the treating ICU team;
• With capacity to give consent or have an appropriate surrogate;
• Able to undergo assessment within 4 hours of the order for enteral feeds;
• Expected to receive enteral feeds for ≥3 days but not yet receiving them.

You may not qualify if:

• Inability to receive enteral feeds;
• Celiac disease or known allergy to fiber;
• Surgery involving the intestinal lumen within 30 days;
• Limited treatment goals (i.e., do-not-resuscitate (DNR), do-not-intubate (DNI), or no escalation of care);
• Lack of capacity to consent and lack of an appropriate legally authorized representative.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel E. Freedberg, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 26, 2018
• Study Start: August 16, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available at the time of publication.
• Access Criteria: Open.

Locations

US (1)