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Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis

Primary Purpose

Early Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KB174
Maltodextrin
Sponsored by
Kaleido Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Early Cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Research Centers of America
  • Advanced Pharma CR, LLC
  • Marquez Clinical Site Partners, LLC Florida Premier Research Institute
  • Delta Research Partners

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

KB174 Arm

Maltodextrin Arm

Arm Description

KB174 is a novel mixture of oligosaccharides.

Maltodextrin is a commercially available easily digestible polysaccharide.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
. 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.
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
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.
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.
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.
Incidence of treatment-emergent adverse events from baseline to end of study.
Incidence of serious adverse events from base baseline to end of study.
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.
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).

Full Information

First Posted
February 25, 2019
Last Updated
May 12, 2020
Sponsor
Kaleido Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT03855956
Brief Title
Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
Official Title
A Randomized, Double-blind, Controlled, Clinical Food Study to Evaluate the Effect of KB174 Compared to an Easily Digestible Polysaccharide on Function and Structure of the Gut Microbiome in Subjects With Well-compensated Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaleido Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Cirrhosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KB174 Arm
Arm Type
Experimental
Arm Description
KB174 is a novel mixture of oligosaccharides.
Arm Title
Maltodextrin Arm
Arm Type
Other
Arm Description
Maltodextrin is a commercially available easily digestible polysaccharide.
Intervention Type
Other
Intervention Name(s)
KB174
Intervention Description
KB174 is a novel mixture of oligosaccharides.
Intervention Type
Other
Intervention Name(s)
Maltodextrin
Intervention Description
Maltodextrin is a commercially available easily digestible polysaccharide.
Primary Outcome Measure Information:
Title
Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Description
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.
Time Frame
Day -3 to Day 28.
Secondary Outcome Measure Information:
Title
Change in 15N in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Description
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.
Time Frame
Day -3 to Day 29.
Title
Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Description
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.
Time Frame
Day -3 to Day 27.
Title
Change in total nitrogen in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Description
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.
Time Frame
Day -3 to Day 29.
Title
. Change in total nitrogen in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Description
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.
Time Frame
Day -3 to Day 29.
Title
Change in ammonia in blood for KB174 compared to Maltodextrin.
Description
Change in ammonia in blood from Baseline to end of study for KB174 compared to maltodextrin
Time Frame
Day -3 to Day 43.
Title
Change in total urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Description
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.
Time Frame
Day -3 to Day 29.
Title
Change in 15N-urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Description
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.
Time Frame
Day -3 to Day 29.
Title
Change in 15N-urea in stool in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Description
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.
Time Frame
Day -3 to Day 29.
Title
Incidence of treatment-emergent adverse events from baseline to end of study.
Time Frame
Day -7 through Day 43 visit.
Title
Incidence of serious adverse events from base baseline to end of study.
Time Frame
Day -7 through Day 43.
Title
Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires.
Description
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.
Time Frame
Day -7 through Day 43.
Title
Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires
Description
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).
Time Frame
Day -7 through Day 43.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Research Centers of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
Marquez Clinical Site Partners, LLC Florida Premier Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Delta Research Partners
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis

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