Loading clinical trials...

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 | Clinical Trials | Clareo Health

TERMINATEDNA

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

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

NCT03944369•Kaleido Biosciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (8)

Harbor UCLA Medical Center

Torrance, California, United States

Emory University

Atlanta, Georgia, United States

Augusta Universtiy

Augusta, Georgia, United States

Newland Immunology Center of Excellence; Providence Hospital

Southfield, Michigan, United States

Stony Brook University

Stony Brook, New York, United States

Atrium Health's Carolinas Medical Center

Charlotte, North Carolina, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Key Dates

Start Date

June 27, 2019

Primary Completion Date

June 16, 2020

Completion Date

June 16, 2020

Last Updated

January 22, 2021

Enrollment

ACTUAL participants

Conditions

Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects

Interventions

KB109

OTHER

No intervention

OTHER