VITORA: Clinical Study to Evaluate the Effect of KB109 on... | NCT03944369

Studies
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

NCT03944369

Sponsor

Kaleido Biosciences

Status

Terminated

Last Update Posted

Jan 22, 2021Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

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

Interventions

KB109
No intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID-19 pandemic

Expanded Access Info

Start Date

Jun 27, 2019Actual

Primary Completion Date

Jun 16, 2020Actual

Completion Date

Jun 16, 2020Actual

First Submitted Date

May 8, 2019

First Submission Date that Met QC Criteria

May 8, 2019

First Posted Date

May 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2021

Last Update Posted Date

Jan 22, 2021Actual

Conditions Module

Conditions

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational Control	Other	The observational control arm is an observational control group.	Other: No intervention
KB109	Other	KB109 is a novel glycan.	Other: KB109

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KB109	Other	KB109 is a novel glycan	KB109
No intervention

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Harbor UCLA Medical Center		Torrance	California	90509	United States
Emory University