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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

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.

Condition or disease Intervention/treatment Phase
Early Cirrhosis Other: KB174 Other: Maltodextrin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: KB174 Arm
KB174 is a novel mixture of oligosaccharides.
Other: KB174
KB174 is a novel mixture of oligosaccharides.

Maltodextrin Arm
Maltodextrin is a commercially available easily digestible polysaccharide.
Other: Maltodextrin
Maltodextrin is a commercially available easily digestible polysaccharide.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855956


Contacts
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Contact: Margaret Koziel, MD 617-674-9000 info@kaleido.com

Locations
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United States, Florida
Research Centers of America Recruiting
Hollywood, Florida, United States, 33024
Contact: Danays Hidalgo    954-990-7649    danays.hidalgo@rcatrials.com   
Advanced Pharma CR, LLC Recruiting
Miami, Florida, United States, 33147
Contact: Ivette Lopez, CCRC    305-220-2727    ilopez@advancedpharmacr.com   
Marquez Clinical Site Partners, LLC Florida Premier Research Institute Recruiting
Winter Park, Florida, United States, 32789
Contact: Faisal Fakih, MD    407-740-8078    jolaya@fpri.com   
United States, Louisiana
Delta Research Partners Recruiting
Monroe, Louisiana, United States, 71201
Contact: Casey Petrus    318-281-6040    CPetrus@gastromds.com   
Sponsors and Collaborators
Kaleido Biosciences
Investigators
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Study Director: Margaret Koziel, MD Kaleido Biosciences

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Responsible Party: Kaleido Biosciences
ClinicalTrials.gov Identifier: NCT03855956     History of Changes
Other Study ID Numbers: K022-118
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases