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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 (VITORA)

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ClinicalTrials.gov Identifier: NCT03944369
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Kaleido Biosciences

Study Description
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Brief Summary:
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 Intervention/treatment Phase
Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects Other: KB109 Other: No intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020
Arms and Interventions
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Arm Intervention/treatment
Observational Control
The observational control arm is an observational control group.
 Other: No intervention
No intervention
KB109
KB109 is a novel glycan.
 Other: KB109
KB109 is a novel glycan


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of product-related treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 through Day 42 ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Day -14 through Day 42 ]
  3. Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires. [ Time Frame: Day -14 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. Change in colonization with VRE, ESBLE, and CRE, combined [ Time Frame: Day -14 to Day 42 ]
  2. Change in colonization with CRE or ESBLE (grouped together) [ Time Frame: Day -14 to Day 42 ]
  3. Change in colonization with CRE (alone) [ Time Frame: Day -14 to Day 42 ]
  4. Change in colonization with ESBLE (alone) [ Time Frame: Day -14 to Day 42 ]
  5. Change in colonization with VRE (alone). [ Time Frame: Day -14 to Day 42 ]

Eligibility Criteria
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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 VRE, ESBLE or CRE
  • Be willing and able to give informed consent
  • Be willing to comply with the required activities during this study
  • Be willing to continue taking any current medications and dietary supplements for the duration of the study
  • If taking probiotic or prebiotic dietary supplements, usage must be consistent within 7 days prior to the run-in period 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 two highly effective methods of contraception for the duration of the study and for 90 days after the last intake of study product
  • If subject is male and has a female partner of childbearing potential, must agree to abstain from sexual activity or agree to use a highly effective contraceptive method for the duration of the study and 90 days after last intake of study product
  • Not requiring acute hospitalization or long-term acute care at run-in (nursing home care is permitted) (Part A only)
  • Not receiving renal replacement therapy (Part A only)

Exclusion Criteria:

  • Requiring acute hospitalization at run-in
  • Neutropenia (≤500 absolute neutrophil count per uL)
  • Prior solid organ or allogeneic hematopoietic stem cell transplant
  • Recent (within 6 months) autologous hematopoietic stem cell transplant
  • Inadequate liver function tests Hemodynamic instability
  • Actively treated infection or other condition receiving, within the 7 days prior to run-in
  • Recent history (within 4 weeks of run-in) of the following conditions requiring medical attention or treatment, including over-the-counter medications: known or suspected gastrointestinal (GI) infection (e.g. viral or bacterial gastroenteritis) or inflammatory bowel disease
  • History of gastroesophageal, small or large bowel resection or anastomosis
  • History of major GI surgery, 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944369


Contacts
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Contact: Michael Mahowald, MD, PhD (617) 674-9000 clinicalstudies@kaleido.com

Locations
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United States, Georgia
Augusta Universtiy Not yet recruiting
Augusta, Georgia, United States, 301912
Contact       idresearch@augusta.edu   
United States, Michigan
Newland Immunology Center of Excellence; Providence Hospital Recruiting
Southfield, Michigan, United States, 48075
Contact       Dobrina.Yankova@acension.org   
Sponsors and Collaborators
Kaleido Biosciences
Investigators
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Study Director: Michael Mahowald, MD, PhD Kaleido Boisciences
More Information
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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: June 27, 2019
Last Verified: June 2019

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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)
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