SepsisNCT03509753
Prebiotic Fiber to Prevent Pathogen Colonization in the ICU
A study testing High Fiber and Low Fiber in people with Sepsis, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- High Fiber and Low Fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- High Fiber, Low Fiber
- Keywords
- Prebiotic fiber
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High FiberDietary supplement
See intervention description.
Low FiberDietary supplement
See intervention description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Low Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start16 Aug 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Freedberg, Columbia University
- Investigators
- Daniel E. Freedberg, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509753
- Sponsor's protocol ID
- AAAR5162
- Other IDs
- 1K23DK111847-01
- Status last verified
- Sep 2019
- First submitted
- 17 Apr 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prebiotic Fiber to Prevent Pathogen Colonization in the Intensive Care Unit (ICU)
- ClinicalTrials.gov ID
- NCT03509753
- Acronym / sponsor ID
- AAAR5162
- Conditions
- Sepsis
- Keywords
- Prebiotic fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Fiber | Experimental | Dietary Supplement: High FiberPer 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. |
| Low Fiber | Active comparator | Dietary Supplement: Low FiberPer 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High FiberSee intervention description. | Dietary supplement | High Fiber |
| Low FiberSee intervention description. | Dietary supplement | Low Fiber |
Primary outcome
Change in microbiome measured by LEfSe
Time frame: Baseline and Day 3
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel E. Freedberg, MD, MS principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Fiber and Low Fiber in people with Sepsis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microbiome measured by LEfSe (time frame: Baseline and Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.