Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT03944369
Status:
TERMINATED
Last Update Posted:
2021-01-22
First Post:
2019-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Kaleido Biosciences
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITORA
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: