- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03855956
Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
May 12, 2020 updated by: Kaleido Biosciences
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Hollywood, Florida, United States, 33024
- Research Centers of America
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Miami, Florida, United States, 33147
- Advanced Pharma CR, LLC
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Winter Park, Florida, United States, 32789
- Marquez Clinical Site Partners, LLC Florida Premier Research Institute
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Louisiana
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Monroe, Louisiana, United States, 71201
- Delta Research Partners
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: KB174 Arm
KB174 is a novel mixture of oligosaccharides.
|
KB174 is a novel mixture of oligosaccharides.
|
Other: Maltodextrin Arm
Maltodextrin is a commercially available easily digestible polysaccharide.
|
Maltodextrin is a commercially available easily digestible polysaccharide.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 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.
|
Day -3 to Day 28.
|
Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: 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.
|
Day -3 to Day 29.
|
Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
Time Frame: 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.
|
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.
Time Frame: 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.
|
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.
Time Frame: 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.
|
Day -3 to Day 29.
|
Change in ammonia in blood for KB174 compared to Maltodextrin.
Time Frame: Day -3 to Day 43.
|
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.
Time Frame: 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.
|
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.
Time Frame: 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.
|
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.
Time Frame: 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.
|
Day -3 to Day 29.
|
Incidence of treatment-emergent adverse events from baseline to end of study.
Time Frame: Day -7 through Day 43 visit.
|
Day -7 through Day 43 visit.
|
|
Incidence of serious adverse events from base baseline to end of study.
Time Frame: Day -7 through Day 43.
|
Day -7 through Day 43.
|
|
Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires.
Time Frame: 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.
|
Day -7 through Day 43.
|
Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires
Time Frame: 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).
|
Day -7 through Day 43.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2019
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
February 25, 2019
First Submitted That Met QC Criteria
February 26, 2019
First Posted (Actual)
February 27, 2019
Study Record Updates
Last Update Posted (Actual)
May 14, 2020
Last Update Submitted That Met QC Criteria
May 12, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K022-118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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