Prebiotic Fiber to Prevent Pathogen Colonization in the ICU

NCT ID: NCT03509753

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-16
• Study Completion Date: 2019-08-01

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.

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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High Fiber

Intervention Type: DIETARY_SUPPLEMENT

See intervention description.

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.

Group Type: ACTIVE_COMPARATOR

Low Fiber

Intervention Type: DIETARY_SUPPLEMENT

See intervention description.

Interventions

High Fiber

See intervention description.

Intervention Type: DIETARY_SUPPLEMENT

Low Fiber

See intervention description.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Freedberg

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel E. Freedberg, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

1K23DK111847-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR5162

Identifier Type: -

Identifier Source: org_study_id