A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function
An Exploratory, 14-week, Open-label Clinical Food Study to Evaluate the Effects of KB295 in Adult Patients With Ulcerative Colitis (UC) Presenting With Mild-to-moderate UC Symptoms
1 other identifier
interventional
12
2 countries
3
Brief Summary
This exploratory, open-label clinical study aims to explore the effects of KB295, a novel glycan, on adult patients with ulcerative colitis (UC) presenting with mild-to-moderate UC symptoms
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2020
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2020
CompletedFirst Posted
Study publicly available on registry
August 11, 2020
CompletedStudy Start
First participant enrolled
August 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2021
CompletedJanuary 24, 2022
January 1, 2022
1.3 years
August 7, 2020
January 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of patients experiencing any treatment-emergent adverse events (TEAEs)
Day -1 to Day 84
Number of patients experiencing discontinuations due to adverse events (AEs)
Day -1 to Day 84
Study Arms (1)
KB295
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Be male or female, ≥18 and ≤75 years of age
- Confirmed diagnosis of UC (\>6 months) by endoscopy
- Mild-to-moderate UC with at least 4 weeks of UC symptomatology prior to screening
- Stable medication regimen for at least 2 weeks prior to screening, if on medication for UC
You may not qualify if:
- Possible or confirmed diagnosis of Crohn's disease or indeterminate disease
- History of isolated distal proctitis
- Use of any antidiarrheal medications within the last 1 week prior to screening
- Antibiotic treatment within the past 28 days prior to screening
- Any non-UC related immunosuppressive medications other than purine analogs. Systemic corticosteroids including prednisone \> 10 mg per day are excluded.
- Major intra-abdominal surgery related to the bowel within 24 weeks prior to the screening period and/or planned invasive surgery/hospitalization during the study
- Major medical comorbidities, or other conditions in the opinion of the PI, that might impact the patient's safety or compliance, or the interpretation of the study results
- Treatment with any other investigational drugs within 28 days prior to the screening visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Atlantia Food Clinical Trials
Chicago, Illinois, 60611, United States
Elligo Health Research, Inc.
Austin, Texas, 78738, United States
Atlantia Food Clinical Trials
Cork, T23 R50R, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Wingertzahn, PhD
Kaleido Biosciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2020
First Posted
August 11, 2020
Study Start
August 12, 2020
Primary Completion
November 29, 2021
Study Completion
November 29, 2021
Last Updated
January 24, 2022
Record last verified: 2022-01