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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects

Intervention / Treatment
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* Other: KB109
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Observational Control<br>The observational control arm is an observational control group. | Other: No intervention<br>* No intervention<br>|
| Other: KB109<br>KB109 is a novel glycan. | Other: KB109<br>* KB109 is a novel glycan<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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