Purpose

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 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)

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

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030

More Details

NCT ID
NCT03944369
Status
Recruiting
Sponsor
Kaleido Biosciences

Study Contact

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

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.