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

Not Applicable

Terminated

• Conditions: Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects
• Interventions: Other: KB109; Other: No intervention

• Registration Number: NCT03944369
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-09
• Study Start: 2019-06-27
• Primary Completion: 2020-06-16
• Study Completion: 2020-06-16
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KB109	KB109	KB109 is a novel glycan.
Observational Control	No intervention	The observational control arm is an observational control group.

Primary Outcome Measures

Name	Time	Method
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.	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

Name	Time	Method
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

Trial Locations

Locations (8)

Stony Brook University; 🇺🇸 Stony Brook, New York, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

Newland Immunology Center of Excellence; Providence Hospital; 🇺🇸 Southfield, Michigan, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Atrium Health's Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Augusta Universtiy; 🇺🇸 Augusta, Georgia, United States

Harbor UCLA Medical Center; 🇺🇸 Torrance, California, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States