Trial Outcomes & Findings for Inulin for Infections in the Intensive Care Unit (NCT NCT03865706)
NCT ID: NCT03865706
Last Updated: 2025-06-19
Results Overview
Relative abundance (i.e., proportion) of SCFA producing bacteria within each treatment group, will be assessed via 16S sequencing of rectal swabs. Modified intent-to-treat, comparing baseline vs Day 3 levels of SCFAs among those who receive one or more doses of the intervention and complete both assessments.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
Baseline and Day 3
Results posted on
2025-06-19
Participant Flow
Participant milestones
| Measure |
Placebo
Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.
Placebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 16 g/Day
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 32 g/Day
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
31
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.
Placebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 16 g/Day
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 32 g/Day
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
3
|
1
|
Baseline Characteristics
Inulin for Infections in the Intensive Care Unit
Baseline characteristics by cohort
| Measure |
Placebo
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.
Placebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 16 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 32 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=93 Participants
|
62 years
n=4 Participants
|
65 years
n=27 Participants
|
62 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
50 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
35 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
35 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=93 Participants
|
30 participants
n=4 Participants
|
30 participants
n=27 Participants
|
90 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 3Relative abundance (i.e., proportion) of SCFA producing bacteria within each treatment group, will be assessed via 16S sequencing of rectal swabs. Modified intent-to-treat, comparing baseline vs Day 3 levels of SCFAs among those who receive one or more doses of the intervention and complete both assessments.
Outcome measures
| Measure |
Placebo
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.
Placebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 16 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 32 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
|---|---|---|---|
|
Within-individual Change in SCFA Producer Level
|
-0.0 percentage of SCFA producers
Interval -7.9 to 7.4
|
-1.8 percentage of SCFA producers
Interval -8.9 to 3.7
|
1.1 percentage of SCFA producers
Interval -12.0 to 11.0
|
SECONDARY outcome
Timeframe: Day 0 and at last sample collected, up to Day 30Proportion of patients who are MDRO-GNB colonized within each treatment group, with MDRO-GNB colonization status classified categorically based on the presence or absence of methicillin-resistant Staphylococcus aureus (MRSA) or Gram negative bacteria (GNB) with third-generation cephalosporins non-susceptibility
Outcome measures
| Measure |
Placebo
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.
Placebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 16 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 32 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
|---|---|---|---|
|
Multidrug Resistant Organism (MDRO)-Gram Negative Bacteria (GNB) Colonization Status
Day 0
|
6 Participants
|
4 Participants
|
3 Participants
|
|
Multidrug Resistant Organism (MDRO)-Gram Negative Bacteria (GNB) Colonization Status
Last Sample Collected, Up to Day 30
|
3 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 0 and at last sample collected, up to Day 30Proportion of patients who are VRE colonized within each treatment group, with VRE colonization status classified categorically based on the presence or absence of vancomycin-resistant Enterococcus (VRE)
Outcome measures
| Measure |
Placebo
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.
Placebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 16 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 32 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
|---|---|---|---|
|
Vancomycin-resistant Enterococcus (VRE) Colonization Status
Day 0
|
8 Participants
|
6 Participants
|
4 Participants
|
|
Vancomycin-resistant Enterococcus (VRE) Colonization Status
Last Sample Collected, Up to Day 30
|
11 Participants
|
13 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 3 and 7The SCFAs butyrate, acetate, and propionate will be measured from whole stools on a 6490 triple quadrupole mass spectrometer and compared between intervention groups using the first stool sample produced after the Day 3 assessment. Patients who fail to produce a stool from Day 3 to 7 will be excluded from this analysis.
Outcome measures
| Measure |
Placebo
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.
Placebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 16 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 32 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
|---|---|---|---|
|
Fecal Short Chain Fatty Acid (SCFA) Levels
Day 3
|
0 mMol
Interval 0.0 to 0.18
|
0.11 mMol
Interval 0.0 to 0.66
|
0 mMol
Interval 0.0 to 0.46
|
|
Fecal Short Chain Fatty Acid (SCFA) Levels
Day 7
|
0 mMol
Interval 0.0 to 0.06
|
0.29 mMol
Interval 0.0 to 0.63
|
0 mMol
Interval 0.0 to 0.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: through ICU Day 30compared between groups, after adjusting for death as a competing risk
Outcome measures
| Measure |
Placebo
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.
Placebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 16 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 32 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
|---|---|---|---|
|
ICU Length of Stay (LOS)
|
9.5 days
Interval 6.0 to 20.0
|
10.5 days
Interval 6.0 to 23.0
|
9 days
Interval 6.0 to 17.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: through 30 daysproportion of patients with culture-proven infections within each treatment group, with culture-proven infections defined as those that have (1) an organism meeting MDRO criteria from a clinical culture, (2) signs and symptoms of infection by Centers for Disease Control (CDC)/National Health and Safety Network (NHSN) guideline definitions, and (3) receive appropriate antibiotics from the treating team
Outcome measures
| Measure |
Placebo
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.
Placebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 16 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 32 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
|---|---|---|---|
|
Multidrug Resistant (MDR) Infections
|
15 Participants
|
9 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 90Death data will be extracted from the hospital electronic medical record (EMR) which immediately captures in-hospital death and receives monthly mortality updates from the National social security death index.
Outcome measures
| Measure |
Placebo
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.
Placebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 16 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 32 g/Day
n=30 Participants
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
|---|---|---|---|
|
Mortality
|
7 Participants
|
7 Participants
|
9 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 7 deaths
Inulin 16 g/Day
Serious events: 0 serious events
Other events: 11 other events
Deaths: 7 deaths
Inulin 32 g/Day
Serious events: 0 serious events
Other events: 15 other events
Deaths: 9 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=30 participants at risk
Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.
Placebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 16 g/Day
n=30 participants at risk
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
Inulin 32 g/Day
n=30 participants at risk
Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.
Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
Broad-spectrum antibiotics: Standard of care treatment for infections
|
|---|---|---|---|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/30 • Up to Day 90
Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
|
6.7%
2/30 • Up to Day 90
Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
|
0.00%
0/30 • Up to Day 90
Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
12/30 • Up to Day 90
Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
|
36.7%
11/30 • Up to Day 90
Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
|
50.0%
15/30 • Up to Day 90
Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30 • Up to Day 90
Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
|
0.00%
0/30 • Up to Day 90
Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
|
3.3%
1/30 • Up to Day 90
Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
|
|
Infections and infestations
Culture Proven Infection
|
50.0%
15/30 • Up to Day 90
Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
|
30.0%
9/30 • Up to Day 90
Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
|
40.0%
12/30 • Up to Day 90
Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place