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)

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

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.

Study Overview

• Status: Terminated
• Conditions: Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects
• Intervention / Treatment: Other: No intervention; Other: KB109

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90509
      • Harbor Ucla Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Augusta, Georgia, United States, 301912
      • Augusta Universtiy
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Newland Immunology Center of Excellence; Providence Hospital
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Atrium Health's Carolinas Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Observational Control; The observational control arm is an observational control group.	Other: No intervention; No intervention
Other: KB109; KB109 is a novel glycan.	Other: KB109; KB109 is a novel glycan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of product-related treatment-emergent adverse events (TEAEs)		Day -7 through Day 42
Incidence of serious adverse events (SAEs)		Day -7 through Day 42
Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires.	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)	Day -7 through Day 42]

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Day -1 to Day 28

Collaborators and Investigators

• Sponsor: Kaleido Biosciences
• Investigators: Study Director: Mark Wingertzahn, PhD, Kaleido Boisciences

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Actual): June 16, 2020
• Study Completion (Actual): June 16, 2020

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Microbiome; Antibiotic resistance; Kaleido; KB109; Glycan; Vancomycin-resistant Enterococcus (VRE); Drug resistant; Microbiome Metabolic Therapy (MMT); Oligosaccharide; Carbapenem-Resistant Enterobacteriaceae (CRE); Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae (ESBLE); Multi Drug Resistant Organism (MDRO); VITORA
• Other Study ID Numbers: K017-119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No