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This randomized, double-blind, controlled, clinical food study aims to explore KB174, a novel mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut microbiome structure and function in subjects with well-compensated cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KB174 Arm | Experimental | KB174 is a novel mixture of oligosaccharides. |
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| Maltodextrin Arm | Other | Maltodextrin is a commercially available easily digestible polysaccharide. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KB174 | Other | KB174 is a novel mixture of oligosaccharides. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Change in 15N in urine in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post-28-day study compound compound consumption. | Day -3 to Day 28. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 15N in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Change in 15N in stool in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post 28-day study compound consumption. | Day -3 to Day 29. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centers of America | Hollywood | Florida | 33024 | United States | ||
| Advanced Pharma CR, LLC |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin |
| Other |
Maltodextrin is a commercially available easily digestible polysaccharide. |
|
| Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. |
Change in total nitrogen in blood in response to an amino acid challenge during Baseline [pre-study compound consumption] versus post 28-day study compound consumption. |
| Day -3 to Day 27. |
| Change in total nitrogen in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Change in total nitrogen in urine in response to an amino acid challenge during Baseline [pre study compound consumption] versus post 28-day study compound consumption. | Day -3 to Day 29. |
| . Change in total nitrogen in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Change in total nitrogen in stool in response to an amino acid challenge during Baseline [pre study compound consumption] versus post 28-day study compound consumption. | Day -3 to Day 29. |
| Change in ammonia in blood for KB174 compared to Maltodextrin. | Change in ammonia in blood from Baseline to end of study for KB174 compared to maltodextrin | Day -3 to Day 43. |
| Change in total urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Change in total urea in urine in response to an amino acid challenge during baseline [pre study compound consumption] versus post 28-day compound consumption. | Day -3 to Day 29. |
| Change in 15N-urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Change in 15N-urea in urine in response to an amino acid challenge from baseline [pre study compound consumption ] versus post 28-day compound consumption. | Day -3 to Day 29. |
| Change in 15N-urea in stool in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin. | Change in 15N-urea in stool in response to an amino acid challenge from baseline [pre study compound consumption ] versus post 28-day compound consumption. | Day -3 to Day 29. |
| Incidence of treatment-emergent adverse events from baseline to end of study. | Day -7 through Day 43 visit. |
| Incidence of serious adverse events from base baseline to end of study. | Day -7 through Day 43. |
| Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires. | Evaluate the effect of KB195 on self-report questionnaires including the Gastrointestinal Tolerability Questionnaire, an assessment of the frequency and severity of GI symptoms, e.g., gas, abdominal pain, calculated on a scale from 0 (None/Not applicable) to a maximum score of 60 (Severe/Much more than usual) for all questions. | Day -7 through Day 43. |
| Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires | Evaluate the effect of KB195 on self-report questionnaires including the Bristol Stool Scale, an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid). | Day -7 through Day 43. |
| Miami |
| Florida |
| 33147 |
| United States |
| Marquez Clinical Site Partners, LLC Florida Premier Research Institute | Winter Park | Florida | 32789 | United States |
| Delta Research Partners | Monroe | Louisiana | 71201 | United States |