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)
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ClinicalTrials.gov Identifier: NCT03944369 |
Recruitment Status :
Terminated
(COVID-19 pandemic)
First Posted : May 9, 2019
Last Update Posted : January 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects | Other: KB109 Other: No intervention | Not Applicable |
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.
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Other: No intervention
No intervention |
KB109
KB109 is a novel glycan.
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Other: KB109
KB109 is a novel glycan |
- Incidence of product-related treatment-emergent adverse events (TEAEs) [ Time Frame: Day -7 through Day 42 ]
- Incidence of serious adverse events (SAEs) [ Time Frame: Day -7 through Day 42 ]
- 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)
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
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 |
Study Director: | Mark Wingertzahn, PhD | Kaleido Boisciences |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |