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出境医 / 临床实验 / VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms (VITORA)

VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms (VITORA)

Study Description
Brief Summary:
This randomized, open-label, clinical study aims to explore the safety and tolerability of KB109, a novel glycan, versus an observational control group on the gut microbiome in subjects whose gastrointestinal tracts are colonized with multiple drug-resistant organisms.

Condition or disease Intervention/treatment Phase
Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects Other: KB109 Other: No intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Clinical Food Study to Assess the Safety, Tolerability, and Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointesinal Tracts Are Colonized With Multiple Drug-resistant Organisms
Actual Study Start Date : June 27, 2019
Actual Primary Completion Date : June 16, 2020
Actual Study Completion Date : June 16, 2020
Arms and Interventions
Arm Intervention/treatment
Observational Control
The observational control arm is an observational control group.
 Other: No intervention
No intervention
KB109
KB109 is a novel glycan.
 Other: KB109
KB109 is a novel glycan
Outcome Measures
Primary Outcome Measures :
  1. Incidence of product-related treatment-emergent adverse events (TEAEs) [ Time Frame: Day -7 through Day 42 ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Day -7 through Day 42 ]
  3. Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires. [ Time Frame: Day -7 through Day 42] ]
    Evaluate the effect of KB109 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)


Secondary Outcome Measures :
  1. 1. Proportion of subjects with a reduction from baseline on Day 28 in the relative abundance of taxa of interest (Enterobacteriaceae, Enterococcus, and C. difficile, individually) as measured by metagenomic sequencing. [ Time Frame: Day -1 to Day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be male or female, ≥18 years of age
  • Positive stool culture for at least one of these three organisms: VRE, ESBLE or CRE
  • Be willing and able to give informed consent
  • If taking probiotic or prebiotic dietary supplements, usage must be consistent within 7 days prior to the run-in phase and willing to remain consistent throughout the study
  • If subject is female: subject is surgically sterile or post-menopausal (12 months with no menses without an alternate medical cause); or if subject is a female of childbearing potential, must have a negative urine pregnancy test at Screening, must not be lactating, and must agree to abstain from sexual activity or agree to use one highly effective method of contraception for the duration of the study

Exclusion Criteria:

  • Planned escalation of immunosuppression
  • Neutropenia (≤500 absolute neutrophil count per μL)
  • Allogenic stem cell transplant recipients with ongoing gastrointestinal disease
  • Rapidly progressive or terminal illness
  • Hemodynamic instability, or any other significant systemic, unstable or untreated disease
  • Currently receiving or anticipated to require systemic (oral or IV anti-infective) or gut-directed antibacterial therapy
  • Recent history of the following conditions requiring medical attention: known or suspected gastrointestinal (GI) infection (e.g., viral or bacterial gastroenteritis) or inflammatory bowel disease
  • Major intra-abdominal surgery related to the bowel within the 3 months prior to Run-In
  • Receiving total parenteral nutrition
  • Contraindications, sensitivity, or known allergy to the use of the study product or its components
  • Individuals who, in the opinion of the Investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study procedures (e.g., planned procedures)
Contacts and Locations

Locations
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United States, California
Harbor UCLA Medical Center
Torrance, California, United States, 90509
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Augusta Universtiy
Augusta, Georgia, United States, 301912
United States, Michigan
Newland Immunology Center of Excellence; Providence Hospital
Southfield, Michigan, United States, 48075
United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794
United States, North Carolina
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina, United States, 28207
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Kaleido Biosciences
Investigators
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Study Director: Mark Wingertzahn, PhD Kaleido Boisciences
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 9, 2019
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE June 27, 2019
Actual Primary Completion Date June 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • Incidence of product-related treatment-emergent adverse events (TEAEs) [ Time Frame: Day -7 through Day 42 ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Day -7 through Day 42 ]
  • Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires. [ Time Frame: Day -7 through Day 42] ]
    Evaluate the effect of KB109 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 Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Incidencec of product-related treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 through Day 42 ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Day -14 through Day 42 ]
  • 3. Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires. [ Time Frame: Day -14 through Day 42] ]
    Evaluate the effect of KB109 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2020) 		1. Proportion of subjects with a reduction from baseline on Day 28 in the relative abundance of taxa of interest (Enterobacteriaceae, Enterococcus, and C. difficile, individually) as measured by metagenomic sequencing. [ Time Frame: Day -1 to Day 28 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Change in colonization with VRE, ESBLE, and CRE, combined [ Time Frame: Day -14 to Day 42 ]
  • Change in colonization with CRE or ESBLE (grouped together) [ Time Frame: Day -14 to Day 42 ]
  • Change in colonization with CRE (alone) [ Time Frame: Day -14 to Day 42 ]
  • Change in colonization with ESBLE (alone) [ Time Frame: Day -14 to Day 42 ]
  • Change in colonization with VRE (alone). [ Time Frame: Day -14 to Day 42 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms
Official Title  ICMJE A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Clinical Food Study to Assess the Safety, Tolerability, and Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointesinal Tracts Are Colonized With Multiple Drug-resistant Organisms
Brief Summary This randomized, open-label, clinical study aims to explore the safety and tolerability of KB109, a novel glycan, versus an observational control group on the gut microbiome in subjects whose gastrointestinal tracts are colonized with multiple drug-resistant organisms.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Study
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects
Intervention  ICMJE
  • Other: KB109
    KB109 is a novel glycan
  • Other: No intervention
    No intervention
Study Arms  ICMJE
  • Observational Control
    The observational control arm is an observational control group.
    Intervention: Other: No intervention
  • KB109
    KB109 is a novel glycan.
    Intervention: Other: KB109
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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 20, 2021) 		3
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2019) 		64
Actual Study Completion Date  ICMJE June 16, 2020
Actual Primary Completion Date June 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be male or female, ≥18 years of age
  • Positive stool culture for at least one of these three organisms: VRE, ESBLE or CRE
  • Be willing and able to give informed consent
  • If taking probiotic or prebiotic dietary supplements, usage must be consistent within 7 days prior to the run-in phase and willing to remain consistent throughout the study
  • If subject is female: subject is surgically sterile or post-menopausal (12 months with no menses without an alternate medical cause); or if subject is a female of childbearing potential, must have a negative urine pregnancy test at Screening, must not be lactating, and must agree to abstain from sexual activity or agree to use one highly effective method of contraception for the duration of the study

Exclusion Criteria:

  • Planned escalation of immunosuppression
  • Neutropenia (≤500 absolute neutrophil count per μL)
  • Allogenic stem cell transplant recipients with ongoing gastrointestinal disease
  • Rapidly progressive or terminal illness
  • Hemodynamic instability, or any other significant systemic, unstable or untreated disease
  • Currently receiving or anticipated to require systemic (oral or IV anti-infective) or gut-directed antibacterial therapy
  • Recent history of the following conditions requiring medical attention: known or suspected gastrointestinal (GI) infection (e.g., viral or bacterial gastroenteritis) or inflammatory bowel disease
  • Major intra-abdominal surgery related to the bowel within the 3 months prior to Run-In
  • Receiving total parenteral nutrition
  • Contraindications, sensitivity, or known allergy to the use of the study product or its components
  • Individuals who, in the opinion of the Investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study procedures (e.g., planned procedures)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03944369
Other Study ID Numbers  ICMJE K017-119
Has Data Monitoring Committee No
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 Not Provided
Responsible Party Kaleido Biosciences
Study Sponsor  ICMJE Kaleido Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark Wingertzahn, PhD Kaleido Boisciences
PRS Account Kaleido Biosciences
Verification Date January 2021

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

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