Intestinal Microbiota and Barrier Function
Conditions
Brief summary
This study evaluates the effect of a dietary supplement to improve gut health. The participants will take one of six dietary treatments for three weeks, and the gut bacteria and the gut intestinal barrier will be assessed to determine if these dietary treatments beneficially change these markers of gut health.
Detailed description
In this study, we intend to test the ecological and therapeutic functionality of a synbiotic combination of a Bifidobacterium adolescentis strain and the prebiotic galactooligosaccharide (GOS) in a human clinical trial. The synbiotic combination was selected based on a novel in vivo selection; specifically, the strain (BD1) is an human autochthonous gut organism that was enriched in an individual by GOS. Our experiments will test the efficacy of this synbiotic compared to a conventional synbiotic. We hypothesize this rationally selected synbiotic will improve intestinal barrier function in obese adult subjects, thereby preventing endotoxemia and metabolic inflammation, physiologically relevant functions that are increased in obese individuals. Our objectives are to: (1) compare the ability of the test and control synbiotic preparations to alter the gut microbiota in obese individuals; (2) test if GOS supports colonization and metabolic activity of test and control strains in the human gut; (3) compare the ability of the two synbiotic preparations to improve intestinal permeability and endotoxemia in obese subjects; and (4) assess associations between the gut microbiota and the test strain with biomarkers for translocation and endotoxemia.
Interventions
DIETARY_SUPPLEMENTBifidobacteria adolescentis BD1
packet containing 10\^9 cells of Bifidobacteria adolescentis BD1
DIETARY_SUPPLEMENTBifidobacteria animalis subsp. lactis BB-12
packet containing 10\^9 cells of Bifidobacteria animalis subsp. lactis BB-12
DIETARY_SUPPLEMENTBifidobacteria adolescentis BD1 and galactooligosaccharide
packet containing 10\^9 cells Bifidobacteria adolescentis BD1 and 5 g galactooligosaccharide
DIETARY_SUPPLEMENTBifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharide
packet containing 10\^9 cells B animalis subsp. lactis BB-12 and 5 g galactooligosaccharide
DIETARY_SUPPLEMENTgalactooligosaccharide
5 g galactooligosaccharide
DIETARY_SUPPLEMENTPlacebo
lactose powder, 5 grams
Sponsors
University of Nebraska Lincoln
University of Alberta
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-65 yrs, obese (30 kg/m2 and greater)
Exclusion criteria
* (1) prior intestinal resection, (2) patient history of GI diseases except for hiatal hernia, GERD, hemorrhoids, (3) severe renal disease defined by creatinine more than twice normal, (4) markedly abnormal liver function defined by ALT/AST over 4 times normal levels or elevated bilirubin (5) antibiotic use within the last 12 weeks prior to enrollment, (6) lean or overweight (BMI \< 30 kg/m2), (7) intolerant to aspirin, (8) regular use of aspirin, (9) excessive alcohol intake (\>2 drinks for men, 1 drink for women daily), (10) presence of uncontrolled chronic metabolic disease (cardiovascular disease, insulin requiring diabetes or uncontrolled diabetes, cancer, etc, (11) a plan to have a major change in dietary habit during the following 6 months, (12) consumption of probiotics, prebiotics or synbiotics without an appropriate 4 week washout period, (13) lactose intolerance or malabsorption; (14) subjects younger than 18 or older than 65, (15) unwillingness to consent to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | baseline and three weeks | change in microbiota composition, including presence of B. adolescentis BD1 and B. animalis supsp lactis BB-12 |
| Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | baseline and three weeks | Change in intestinal permeability as measured by change in percent sugars in urine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | baseline and three weeks | Endotoxemia, as measured by change in circulating endotoxin by lipopolysaccharide and lipopolysaccharide-binding protein |
Countries
United States
Participant flow
Pre-assignment details
151 subjects enrolled. Of these, 37 subjects discontinued trial prior to treatment randomization due to loss to follow-up (n=12), subject no longer interested (n=9), laboratory values outside range (n=5), and other (n=11).
Participants by arm
| Arm | Count |
|---|---|
| Placebo 5 g lactose given as a placebo | 17 |
| Probiotic 1 Bifidobacteria adolescentis BD1, 10\^9 | 14 |
| Probiotic 2 Bifidobacteria animalis subsp. lactis BB-12, 10\^9 | 14 |
| Synbiotic 1 galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10\^9) | 16 |
| Synbiotic 2 galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10\^9) | 17 |
| Prebiotic galactooligosaccaride, 5 g | 16 |
| Total | 94 |
Baseline characteristics
| Characteristic | Placebo | Probiotic 1 | Probiotic 2 | Synbiotic 1 | Synbiotic 2 | Prebiotic | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 43.9 years STANDARD_DEVIATION 8.8 | 44.7 years STANDARD_DEVIATION 13.3 | 43.9 years STANDARD_DEVIATION 12.5 | 44.2 years STANDARD_DEVIATION 11.8 | 43.1 years STANDARD_DEVIATION 12.7 | 45.9 years STANDARD_DEVIATION 9.6 | 44.3 years STANDARD_DEVIATION 11.2 |
| Education Greater than 12 years | 14 Participants | 13 Participants | 12 Participants | 10 Participants | 15 Participants | 10 Participants | 74 Participants |
| Education Less than or equal to 12 years | 3 Participants | 1 Participants | 2 Participants | 6 Participants | 2 Participants | 6 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 12 Participants | 12 Participants | 14 Participants | 15 Participants | 15 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity African American | 10 Participants | 6 Participants | 7 Participants | 13 Participants | 11 Participants | 11 Participants | 58 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Ethnicity White | 5 Participants | 8 Participants | 4 Participants | 3 Participants | 6 Participants | 5 Participants | 31 Participants |
| Region of Enrollment United States | 17 participants | 14 participants | 14 participants | 16 participants | 17 participants | 16 participants | 94 participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 12 Participants | 11 Participants | 12 Participants | 12 Participants | 69 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 2 Participants | 5 Participants | 5 Participants | 4 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 14 | 0 / 14 | 0 / 16 | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 0 / 17 | 0 / 14 | 0 / 14 | 0 / 16 | 0 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 14 | 0 / 14 | 0 / 16 | 0 / 17 | 0 / 16 |
Outcome results
Primary
Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine
Change in intestinal permeability as measured by change in percent sugars in urine
Time frame: baseline and three weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | Sucralose:Lactulose with aspirin Baseline | 0.32 sucralose:lactulose ratio | Standard Deviation 0.2 |
| Placebo | Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | Sucralose:Lactulose with aspirin Treatment End | 0.36 sucralose:lactulose ratio | Standard Deviation 0.25 |
| Probiotic 1 | Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | Sucralose:Lactulose with aspirin Baseline | 0.34 sucralose:lactulose ratio | Standard Deviation 0.21 |
| Probiotic 1 | Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | Sucralose:Lactulose with aspirin Treatment End | 0.20 sucralose:lactulose ratio | Standard Deviation 0.16 |
| Probiotic 2 | Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | Sucralose:Lactulose with aspirin Baseline | 0.34 sucralose:lactulose ratio | Standard Deviation 0.3 |
| Probiotic 2 | Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | Sucralose:Lactulose with aspirin Treatment End | 0.26 sucralose:lactulose ratio | Standard Deviation 0.18 |
| Synbiotic 1 | Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | Sucralose:Lactulose with aspirin Baseline | 0.32 sucralose:lactulose ratio | Standard Deviation 0.23 |
| Synbiotic 1 | Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | Sucralose:Lactulose with aspirin Treatment End | 0.20 sucralose:lactulose ratio | Standard Deviation 0.16 |
| Synbiotic 2 | Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | Sucralose:Lactulose with aspirin Baseline | 0.36 sucralose:lactulose ratio | Standard Deviation 0.19 |
| Synbiotic 2 | Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | Sucralose:Lactulose with aspirin Treatment End | 0.29 sucralose:lactulose ratio | Standard Deviation 0.16 |
| Prebiotic | Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | Sucralose:Lactulose with aspirin Baseline | 0.37 sucralose:lactulose ratio | Standard Deviation 0.19 |
| Prebiotic | Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine | Sucralose:Lactulose with aspirin Treatment End | 0.23 sucralose:lactulose ratio | Standard Deviation 0.15 |
Primary
Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12
change in microbiota composition, including presence of B. adolescentis BD1 and B. animalis supsp lactis BB-12
Time frame: baseline and three weeks
Population: Mann-Whitney-Wilcoxon matched pair tests
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | Bifidobacterium Baseline | 7.9 percentage of bacterial taxa | Standard Deviation 8.1 |
| Placebo | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | Bifidobacterium Treatment End | 12.0 percentage of bacterial taxa | Standard Deviation 8 |
| Placebo | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_1 (B adolescentis) Baseline | 1.2 percentage of bacterial taxa | Standard Deviation 1.9 |
| Placebo | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_1 (B adolescentis) Treatment End | 2.6 percentage of bacterial taxa | Standard Deviation 4.1 |
| Placebo | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_167 (B. animalis subsp. lactis) Baseline | 0.0 percentage of bacterial taxa | Standard Deviation 0 |
| Placebo | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_167 (B. animalis subsp. lactis) Treatment End | 0.0 percentage of bacterial taxa | Standard Deviation 0.1 |
| Probiotic 1 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | Bifidobacterium Treatment End | 14.6 percentage of bacterial taxa | Standard Deviation 6.9 |
| Probiotic 1 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_1 (B adolescentis) Treatment End | 3.4 percentage of bacterial taxa | Standard Deviation 5.1 |
| Probiotic 1 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_167 (B. animalis subsp. lactis) Treatment End | 0.0 percentage of bacterial taxa | Standard Deviation 0 |
| Probiotic 1 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | Bifidobacterium Baseline | 9.1 percentage of bacterial taxa | Standard Deviation 5.3 |
| Probiotic 1 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_1 (B adolescentis) Baseline | 1.2 percentage of bacterial taxa | Standard Deviation 4.2 |
| Probiotic 1 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_167 (B. animalis subsp. lactis) Baseline | 0.0 percentage of bacterial taxa | Standard Deviation 0 |
| Probiotic 2 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_167 (B. animalis subsp. lactis) Treatment End | 0.1 percentage of bacterial taxa | Standard Deviation 0.1 |
| Probiotic 2 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_167 (B. animalis subsp. lactis) Baseline | 0.0 percentage of bacterial taxa | Standard Deviation 0 |
| Probiotic 2 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_1 (B adolescentis) Treatment End | 1.1 percentage of bacterial taxa | Standard Deviation 1.6 |
| Probiotic 2 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_1 (B adolescentis) Baseline | 1.2 percentage of bacterial taxa | Standard Deviation 2.5 |
| Probiotic 2 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | Bifidobacterium Baseline | 8.8 percentage of bacterial taxa | Standard Deviation 5.7 |
| Probiotic 2 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | Bifidobacterium Treatment End | 9.5 percentage of bacterial taxa | Standard Deviation 8.4 |
| Synbiotic 1 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_1 (B adolescentis) Treatment End | 7.3 percentage of bacterial taxa | Standard Deviation 7 |
| Synbiotic 1 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | Bifidobacterium Treatment End | 14.7 percentage of bacterial taxa | Standard Deviation 7.4 |
| Synbiotic 1 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_1 (B adolescentis) Baseline | 2.5 percentage of bacterial taxa | Standard Deviation 4.5 |
| Synbiotic 1 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_167 (B. animalis subsp. lactis) Treatment End | 0.0 percentage of bacterial taxa | Standard Deviation 0 |
| Synbiotic 1 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_167 (B. animalis subsp. lactis) Baseline | 0.0 percentage of bacterial taxa | Standard Deviation 0 |
| Synbiotic 1 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | Bifidobacterium Baseline | 6.0 percentage of bacterial taxa | Standard Deviation 5.9 |
| Synbiotic 2 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | Bifidobacterium Baseline | 8.7 percentage of bacterial taxa | Standard Deviation 6.2 |
| Synbiotic 2 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_167 (B. animalis subsp. lactis) Baseline | 0.0 percentage of bacterial taxa | Standard Deviation 0 |
| Synbiotic 2 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | Bifidobacterium Treatment End | 15.9 percentage of bacterial taxa | Standard Deviation 8 |
| Synbiotic 2 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_1 (B adolescentis) Baseline | 3.1 percentage of bacterial taxa | Standard Deviation 4.5 |
| Synbiotic 2 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_1 (B adolescentis) Treatment End | 6.8 percentage of bacterial taxa | Standard Deviation 9.6 |
| Synbiotic 2 | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_167 (B. animalis subsp. lactis) Treatment End | 0.1 percentage of bacterial taxa | Standard Deviation 0.2 |
| Prebiotic | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_1 (B adolescentis) Treatment End | 6.6 percentage of bacterial taxa | Standard Deviation 8.8 |
| Prebiotic | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_1 (B adolescentis) Baseline | 3.8 percentage of bacterial taxa | Standard Deviation 7.5 |
| Prebiotic | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_167 (B. animalis subsp. lactis) Baseline | 0.0 percentage of bacterial taxa | Standard Deviation 0 |
| Prebiotic | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | OTU_167 (B. animalis subsp. lactis) Treatment End | 0.2 percentage of bacterial taxa | Standard Deviation 0.9 |
| Prebiotic | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | Bifidobacterium Treatment End | 17.4 percentage of bacterial taxa | Standard Deviation 11.4 |
| Prebiotic | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 | Bifidobacterium Baseline | 11.3 percentage of bacterial taxa | Standard Deviation 10.5 |
Secondary
Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein
Endotoxemia, as measured by change in circulating endotoxin by lipopolysaccharide and lipopolysaccharide-binding protein
Time frame: baseline and three weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | Lipopolysaccharide Baseline | 0.02 EU/mL | Standard Deviation 0.02 |
| Placebo | Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | Lipopolysaccharide Treatment End | 0.02 EU/mL | Standard Deviation 0.04 |
| Probiotic 1 | Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | Lipopolysaccharide Baseline | 0.03 EU/mL | Standard Deviation 0.03 |
| Probiotic 1 | Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | Lipopolysaccharide Treatment End | 0.03 EU/mL | Standard Deviation 0.03 |
| Probiotic 2 | Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | Lipopolysaccharide Baseline | 0.3 EU/mL | Standard Deviation 0.03 |
| Probiotic 2 | Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | Lipopolysaccharide Treatment End | 0.03 EU/mL | Standard Deviation 0.06 |
| Synbiotic 1 | Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | Lipopolysaccharide Baseline | 0.02 EU/mL | Standard Deviation 0.03 |
| Synbiotic 1 | Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | Lipopolysaccharide Treatment End | 0.02 EU/mL | Standard Deviation 0.04 |
| Synbiotic 2 | Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | Lipopolysaccharide Baseline | 0.02 EU/mL | Standard Deviation 0.02 |
| Synbiotic 2 | Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | Lipopolysaccharide Treatment End | 0.02 EU/mL | Standard Deviation 0.02 |
| Prebiotic | Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | Lipopolysaccharide Baseline | 0.02 EU/mL | Standard Deviation 0.02 |
| Prebiotic | Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein | Lipopolysaccharide Treatment End | 0.02 EU/mL | Standard Deviation 0.01 |