Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects Clinical Trial
— VITORAOfficial 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
| NCT number | NCT03944369 |
| Other study ID # | K017-119 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 27, 2019 |
| Est. completion date | June 16, 2020 |
| Verified date | January 2021 |
| Source | Kaleido Biosciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 3 |
| Est. completion date | June 16, 2020 |
| Est. primary completion date | June 16, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University | Atlanta | Georgia |
| United States | Augusta Universtiy | Augusta | Georgia |
| United States | Atrium Health's Carolinas Medical Center | Charlotte | North Carolina |
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Newland Immunology Center of Excellence; Providence Hospital | Southfield | Michigan |
| United States | Stony Brook University | Stony Brook | New York |
| United States | Harbor UCLA Medical Center | Torrance | California |
| Lead Sponsor | Collaborator |
|---|---|
| Kaleido Biosciences |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of product-related treatment-emergent adverse events (TEAEs) | Day -7 through Day 42 | ||
| Primary | Incidence of serious adverse events (SAEs) | Day -7 through Day 42 | ||
| Primary | 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 | 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 |