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)

• ClinicalTrials.gov Identifier: NCT03944369
• Recruitment Status: Terminated
• First Posted: May 9, 2019
• Last Update Posted: January 22, 2021
• Sponsor: Kaleido Biosciences
• Information provided by (Responsible Party): Kaleido Biosciences

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

• 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

• 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

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

• Study Director: Mark Wingertzahn, PhD; Kaleido Boisciences

More Information

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

• 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