Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
- Conditions
- Early Cirrhosis
- Interventions
- Other: KB174Other: Maltodextrin
- Registration Number
- NCT03855956
- Lead Sponsor
- Kaleido Biosciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Be able and willing to provide written informed consent
- Be male or female, 18 to 70 years of age (inclusive)
- Have a body mass index (BMI) ≥ 20.0 and < 40.0 kg/m2
- Well-compensated cirrhosis
- Negative for hepatocellular carcinoma (HCC)
- Adequate safety laboratory values at Screening.
- Be willing to maintain a stable diet throughout the course of the study, and willing to continue usual exercise routine
- If of child bearing potential must follow contraceptive requirements of the protocol
- Have reliable internet access
- Have evidence of decompensated liver disease.
- History or active GI disease.
- Prior solid organ transplantation, including liver transplantation or on liver transplant waiting list.
- Subject has a history of drug and/or alcohol abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KB174 Arm KB174 KB174 is a novel mixture of oligosaccharides. Maltodextrin Arm Maltodextrin Maltodextrin is a commercially available easily digestible polysaccharide.
- Primary Outcome Measures
Name Time Method Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. Day -3 to Day 28. 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.
- Secondary Outcome Measures
Name Time Method Change in 15N in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. Day -3 to Day 29. 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.
Change in 15N-urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin. Day -3 to Day 29. 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.
Change in 15N-urea in stool in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin. Day -3 to Day 29. 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.
Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. Day -3 to Day 27. 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.
. Change in total nitrogen in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. Day -3 to Day 29. 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.
Change in ammonia in blood for KB174 compared to Maltodextrin. Day -3 to Day 43. Change in ammonia in blood from Baseline to end of study for KB174 compared to maltodextrin
Change in total urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin. Day -3 to Day 29. 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.
Incidence of treatment-emergent adverse events from baseline to end of study. Day -7 through Day 43 visit. Change in total nitrogen in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin. Day -3 to Day 29. 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.
Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires. Day -7 through Day 43. 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.
Incidence of serious adverse events from base baseline to end of study. Day -7 through Day 43. Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires Day -7 through Day 43. 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).
Trial Locations
- Locations (4)
Delta Research Partners
🇺🇸Monroe, Louisiana, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Marquez Clinical Site Partners, LLC Florida Premier Research Institute
🇺🇸Winter Park, Florida, United States
Advanced Pharma CR, LLC
🇺🇸Miami, Florida, United States