NCT03944369: VITORA

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

Terminated NA Last updated 22 January 2021

What this trial tests

NA trial testing KB109 in Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects in 3 participants. Terminated before completion.

Timeline

27 June 2019

Primary endpoint
16 June 2020

16 June 2020

Quick facts

Lead sponsor	Kaleido Biosciences
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	3
Start date	27 June 2019
Primary completion	16 June 2020
Estimated completion	16 June 2020
Sites	8 locations across United States

Drugs / interventions tested

• KB109
• No intervention

Conditions studied

• Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects — all drugs for Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects →

Sponsor

Kaleido Biosciences — full company profile →

Who can join

18 and older, any sex, with Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut Microbiota, Antibiotic Therapy and Antimicrobial Resistance: A Narrative Review.
   Pilmis B, Le Monnier A, Zahar JR. · · 2020 · cited 66× · PMID 32079318 · DOI 10.3390/microorganisms8020269
2. The Role of Probiotics, Prebiotics and Synbiotics in Combating Multidrug-Resistant Organisms.
   Newman AM, Arshad M. · · 2020 · cited 40× · PMID 32800382 · DOI 10.1016/j.clinthera.2020.06.011
3. Gut Microbiota Modulation: Implications for Infection Control and Antimicrobial Stewardship.
   Tan GSE, Tay HL, Tan SH, Lee TH, et al · · 2020 · cited 21× · PMID 32767183 · DOI 10.1007/s12325-020-01458-z
4. Bacterial, Gut Microbiome-Modifying Therapies to Defend against Multidrug Resistant Organisms.
   Feehan A, Garcia-Diaz J. · · 2020 · cited 14× · PMID 31991615 · DOI 10.3390/microorganisms8020166