Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized SubjectsVITORANCT03944369
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
A study testing KB109 in people with Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects, run by Kaleido Biosciences at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects
- What is being tested?
- KB109
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 8 sitesUnited States
- Study dates
- 27 Jun 2019to 16 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University
Atlanta, Georgia, 30322
Augusta Universtiy
Augusta, Georgia, 301912
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina, 28207
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Newland Immunology Center of Excellence; Providence Hospital
Southfield, Michigan, 48075
Stony Brook University
Stony Brook, New York, 11794
Harbor UCLA Medical Center
Torrance, California, 90509
About this study
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
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.
- Being tested
- KB109, No intervention
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB109Other
KB109 is a novel glycan
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Observational Control | Other | The observational control arm is an observational control group. Receives: Other: No intervention |
| KB109 | Other | KB109 is a novel glycan. Receives: Other: KB109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of product-related treatment-emergent adverse events (TEAEs)
Measured: Day -7 through Day 42
Incidence of serious adverse events (SAEs)
Measured: 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)
Measured: Day -7 through Day 42]
Secondary outcomes (1)
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.
Measured: Day -1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start27 Jun 2019
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Study
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaleido Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Wingertzahn, PhD, Study director, Kaleido Boisciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944369
- Sponsor's protocol ID
- K017-119
- Acronym
- VITORA
- Status last verified
- Jan 2021
- First submitted
- 8 May 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03944369
- Acronym / sponsor ID
- VITORA / K017-119
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Kaleido BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Study
| Arm | Type | Receives |
|---|---|---|
| Observational Control | Other | Other: No interventionThe observational control arm is an observational control group. |
| KB109 | Other | Other: KB109KB109 is a novel glycan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KB109KB109 is a novel glycan | Other | KB109 |
| No interventionNo intervention | Other | Observational Control |
Primary outcome
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 secondary outcome
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
Results and safety
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Wingertzahn, PhD study director
Kaleido Boisciences
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KB109 in people with Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects, run by Kaleido Biosciences at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of product-related treatment-emergent adverse events (TEAEs) (time frame: Day -7 through Day 42). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.