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

Stopped early · Not applicable

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

In brief

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.

Key facts

Study ID

NCT03944369

Run by

Kaleido Biosciences

People needed

3

Starts

2019-06-27

Expected to finish

2020-06-16

Last updated by the study team

2021-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Harbor UCLA Medical Center — Torrance, California, United States
• Emory University — Atlanta, Georgia, United States
• Augusta Universtiy — Augusta, Georgia, United States
• Newland Immunology Center of Excellence; Providence Hospital — Southfield, Michigan, United States
• Stony Brook University — Stony Brook, New York, United States
• Atrium Health's Carolinas Medical Center — Charlotte, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.