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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03944369
Recruitment Status : Terminated (COVID-19 pandemic)
First Posted : May 9, 2019
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Kaleido Biosciences

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

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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

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




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 ]


Information from the National Library of Medicine

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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)

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): NCT03944369


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
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Responsible Party: Kaleido Biosciences
ClinicalTrials.gov Identifier: NCT03944369    
Other Study ID Numbers: K017-119
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaleido Biosciences:
Microbiome
Antibiotic resistance
Carbapenem-Resistant Enterobacteriaceae (CRE)
Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae (ESBLE)
Vancomycin-resistant Enterococcus (VRE)
Multi Drug Resistant Organism (MDRO)
Drug resistant
Kaleido
VITORA
KB109
Microbiome Metabolic Therapy (MMT)
Oligosaccharide
Glycan