Clinical trial NCT03944369: 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: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects
Keywords: 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
Lead sponsor: Kaleido Biosciences
Sponsor class: INDUSTRY
First posted: 2019-05-09
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Study
Primary purpose: OTHER

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.


Eligibility 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)

Primary outcomes:
measure: Incidence of product-related treatment-emergent adverse events (TEAEs)
timeFrame: Day -7 through Day 42
measure: Incidence of serious adverse events (SAEs)
timeFrame: Day -7 through Day 42
measure: Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires.
timeFrame: Day -7 through Day 42]
Secondary outcomes:
measure: 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.
timeFrame: Day -1 to Day 28
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Augusta Universtiy
state: Georgia
city: Southfield
country: United States
facility: Newland Immunology Center of Excellence; Providence Hospital
state: Michigan
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Charlotte
country: United States
facility: Atrium Health's Carolinas Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: Kaleido Boisciences
name: Mark Wingertzahn, PhD
role: STUDY_DIRECTOR
References: