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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

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

Clinicaltrials.gov identifier NCT03944369

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted March 12, 2020

Study Description

Brief 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.

  • Condition or Disease:Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects
  • Intervention/Treatment: Other: KB109
    Other: No intervention
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Study
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • 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
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: November 2020
Arms and interventions
Arm Intervention/treatment
Other: KB109
KB109 is a novel glycan.
Other: KB109
KB109 is a novel glycan
Other: Observational Control
The observational control arm is an observational control group.
Other: No intervention
No intervention
Outcome Measures
  • Primary Outcome Measures: 1. Incidence of product-related treatment-emergent adverse events (TEAEs) [ Time Frame: Day -7 through Day 42 ]
  • 2. Incidence of serious adverse events (SAEs) [ Time Frame: Day -7 through Day 42 ]
  • 3. 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)
  • Secondary Outcome Measures: 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. [ Time Frame: Day -1 to Day 28 ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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)

Contacts and Locations
Contacts

Contact: Mark Wingertzahn, PhD (617) 674-9000 clinicalstudies@kaleido.com

Locations

United States, California
Harbor UCLA Medical Center
Torrance

United States, Georgia
Emory University
Atlanta

United States, Georgia
Augusta Universtiy
Augusta

United States, Michigan
Newland Immunology Center of Excellence; Providence Hospital
Southfield

United States, New York
Stony Brook University
Stony Brook

United States, North Carolina
Atrium Health's Carolinas Medical Center
Charlotte

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh

United States, Texas
The University of Texas Health Science Center at Houston
Houston

Sponsors and Collaborators

Kaleido Biosciences

Investigators

Study Director: Mark Wingertzahn, PhD Kaleido Boisciences

More Information
  • Responsible Party: Kaleido Biosciences
  • ClinicalTrials.gov Identifier: NCT03944369 History of Changes
  • Other Study ID Numbers: K017-119
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: March 12, 2020
  • Last Verified: March 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Kaleido Biosciences: Microbiome
    Antibiotic resistance
    Carbapenem-Resistant Enterobacteriaceae (CRE)
    Multi Drug Resistant Organism (MDRO)
    Kaleido
    VITORA
    KB109
    Microbiome Metabolic Therapy (MMT)
    Oligosaccharide
    Glycan
    Drug resistant
    Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae (ESBLE)
    Vancomycin-resistant Enterococcus (VRE)