Prebiotic Fiber to Prevent Pathogen Colonization in the ICU

Prebiotic Fiber to Prevent Pathogen Colonization in the Intensive Care Unit (ICU)

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Dietary supplement: High Fiber; Dietary supplement: Low Fiber

Detailed Description

This study will test prebiotic fiber in 20 adults who are receiving broad-spectrum antibiotics in the medical or surgical ICU by open-label randomization of patients to approximately 20 g prebiotic fiber/day including 45% short-chain fructooligosaccharides versus 0 g fiber/day by providing one of two feeds. Per 10 ounces of feed, both the high and low fiber feeds contain identical micronutrients and have 296 kilocalorie (kCal), 19 g protein, 8 g fat, and 39 g carbohydrates. The sole difference is that the fiber-containing feed has 4 g fiber including 45% short-chain fructooligosaccharides per 10 ounces whereas the other feed has 0 g fiber. Randomization will take place at the time the order for enteral feeding is placed. Rather than supplying the feed itself, the investigators will supply a randomized recommendation for a feed type (i.e., high vs low fiber) and the feed will be obtained from the hospital pharmacy in the usual manner. Determination of the feed rate and duration will be decided on the individual patient's needs by the treating ICU team. The primary outcome will be to determine whether high fiber feeds alter the gut microbiome in the face of antibiotics and critical illness, calculated by comparing within-individual microbiome differences from baseline to Day 3 in each intervention group.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Fiber; 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; See intervention description.
Active Comparator: Low Fiber; 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; See intervention description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Daniel E. Freedberg, MD, MS, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Prebiotic fiber
• Other Study ID Numbers: AAAR5162; 1K23DK111847-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sequencing data and corresponding metadata will be made available through the Short Read Archive (SRA) section of the National Center for Biotechnology Information (NCBI) at the time of publication of the study results.
• IPD Sharing Time Frame: Data will be made available at the time of publication.
• IPD Sharing Access Criteria: Open.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No