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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK111847-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Fiber | Dietary Supplement | See intervention description. |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel E. Freedberg, MD, MS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States |
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.
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Data will be made available at the time of publication.
Open.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Low Fiber |
| Dietary Supplement |
See intervention description. |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |