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

Kaleido Biosciences

Status

Terminated

Conditions

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

Treatments

Other: KB109

Other: No intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT03944369

K017-119

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)