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| Name | Class |
|---|---|
| University of Nebraska Lincoln | OTHER |
| University of Alberta | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 5 g lactose given as a placebo |
|
| Probiotic 1 | Experimental | Bifidobacteria adolescentis BD1, 10^9 |
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| Probiotic 2 | Experimental | Bifidobacteria animalis subsp. lactis BB-12, 10^9 |
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| Prebiotic | Experimental | galactooligosaccaride, 5 g |
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| Synbiotic 1 | Experimental | galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10^9) |
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| Synbiotic 2 | Experimental | galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10^9) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacteria adolescentis BD1 | Dietary Supplement | packet containing 10^9 cells of Bifidobacteria adolescentis BD1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and three weeks |
| 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 | baseline and three weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and three weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hutkins, PhD | University of Nebraska Lincoln | Principal Investigator |
| Jens Walter, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29954454 | Derived | Krumbeck JA, Rasmussen HE, Hutkins RW, Clarke J, Shawron K, Keshavarzian A, Walter J. Probiotic Bifidobacterium strains and galactooligosaccharides improve intestinal barrier function in obese adults but show no synergism when used together as synbiotics. Microbiome. 2018 Jun 28;6(1):121. doi: 10.1186/s40168-018-0494-4. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 5 g lactose given as a placebo |
| FG001 | Probiotic 1 | Bifidobacteria adolescentis BD1, 10^9 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bifidobacteria animalis subsp. lactis BB-12 | Dietary Supplement | packet containing 10^9 cells of Bifidobacteria animalis subsp. lactis BB-12 |
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| Bifidobacteria adolescentis BD1 and galactooligosaccharide | Dietary Supplement | packet containing 10^9 cells Bifidobacteria adolescentis BD1 and 5 g galactooligosaccharide |
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| Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharide | Dietary Supplement | packet containing 10^9 cells B animalis subsp. lactis BB-12 and 5 g galactooligosaccharide |
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| galactooligosaccharide | Dietary Supplement | 5 g galactooligosaccharide |
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| Placebo | Dietary Supplement | lactose powder, 5 grams |
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| FG002 |
| Probiotic 2 |
Bifidobacteria animalis subsp. lactis BB-12, 10^9 |
| FG003 | Synbiotic 1 | galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10^9) |
| FG004 | Synbiotic 2 | galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10^9) |
| FG005 | Prebiotic | galactooligosaccharide, 5 g |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics of per-protocol data presented. Thus, participant number is less than the number that completed each arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 5 g lactose given as a placebo |
| BG001 | Probiotic 1 | Bifidobacteria adolescentis BD1, 10^9 |
| BG002 | Probiotic 2 | Bifidobacteria animalis subsp. lactis BB-12, 10^9 |
| BG003 | Synbiotic 1 | galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10^9) |
| BG004 | Synbiotic 2 | galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10^9) |
| BG005 | Prebiotic | galactooligosaccaride, 5 g |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Mann-Whitney-Wilcoxon matched pair tests | Posted | Mean | Standard Deviation | percentage of bacterial taxa | baseline and three weeks |
|
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| ||||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Mean | Standard Deviation | sucralose:lactulose ratio | baseline and three weeks |
| |||||||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Mean | Standard Deviation | EU/mL | baseline and three weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 5 g lactose given as a placebo | 0 | 17 | 0 | 17 | 0 | 17 |
| EG001 | Probiotic 1 | Bifidobacteria adolescentis BD1, 10^9 | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Probiotic 2 | Bifidobacteria animalis subsp. lactis BB-12, 10^9 | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | Synbiotic 1 | galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10^9) | 0 | 16 | 0 | 16 | 0 | 16 |
| EG004 | Synbiotic 2 | galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10^9) | 0 | 17 | 0 | 17 | 0 | 17 |
| EG005 | Prebiotic | galactooligosaccaride, 5 g | 0 | 16 | 0 | 16 | 0 | 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Rasmussen, Assistant Professor | University of Nebraska-Lincoln | 402-472-1373 | hrasmussen2@unl.edu |
| ID | Term |
|---|---|
| C072242 | 4'-galactooligosaccharide |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| African American |
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| Other |
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| Greater than 12 years |
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| Bifidobacterium Treatment End |
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| OTU_1 (B adolescentis) Baseline |
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| OTU_1 (B adolescentis) Treatment End |
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| OTU_167 (B. animalis subsp. lactis) Baseline |
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| OTU_167 (B. animalis subsp. lactis) Treatment End |
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| OG005 |
| Prebiotic |
galactooligosaccharide, 5 g |
|
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| OG005 | Prebiotic | galactooligosaccharide, 5 g |
|
|