Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Study
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Observational Control
The observational control arm is an observational control group.
  • Other: No intervention
    No intervention
Other
KB109
KB109 is a novel glycan.
  • Other: KB109
    KB109 is a novel glycan

More Details

Status
Terminated
Sponsor
Kaleido Biosciences

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.