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Completed

NCT Number: NCT03855956

Clinical Food Study to Evaluate the Effect of KB174 on 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.

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Key information

Conditions

Early Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Centers of America, Hollywood, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KB174

Other

KB174 is a novel mixture of oligosaccharides.

maltodextrin

Other

Maltodextrin is a commercially available easily digestible polysaccharide.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. . 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. Incidence of treatment-emergent adverse events from baseline to end of study.

    Time frame: Day -7 through Day 43 visit.

  10. Incidence of serious adverse events from base baseline to end of study.

    Time frame: Day -7 through Day 43.

  11. 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.

  12. 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).

Sponsors and collaborators

Lead sponsor

Kaleido Biosciences

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2019
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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