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

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ClinicalTrials.gov Identifier: NCT03855956
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Kaleido Biosciences

Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE February 27, 2019
Last Update Posted Date April 15, 2019
Actual Study Start Date  ICMJE February 27, 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03855956 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • 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.
  • 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.
  • 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.
  • . 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.
  • 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
  • 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.
  • 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.
  • 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.
  • Incidence of treatment-emergent adverse events from baseline to end of study. [ Time Frame: 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. ]
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Early Cirrhosis
Intervention  ICMJE
  • Other: KB174
    KB174 is a novel mixture of oligosaccharides.
  • Other: Maltodextrin
    Maltodextrin is a commercially available easily digestible polysaccharide.
Study Arms  ICMJE
  • Experimental: KB174 Arm
    KB174 is a novel mixture of oligosaccharides.
    Intervention: Other: KB174
  • Maltodextrin Arm
    Maltodextrin is a commercially available easily digestible polysaccharide.
    Intervention: Other: Maltodextrin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 26, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Margaret Koziel, MD 617-674-9000 info@kaleido.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03855956
Other Study ID Numbers  ICMJE K022-118
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kaleido Biosciences
Study Sponsor  ICMJE Kaleido Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Margaret Koziel, MD Kaleido Biosciences
PRS Account Kaleido Biosciences
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP