Status:
COMPLETED
A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function
Lead Sponsor:
Kaleido Biosciences
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04508413
Start Date
August 12 2020
End Date
November 29 2021
Last Update
January 24 2022
Active Locations (3)
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1
Atlantia Food Clinical Trials
Chicago, Illinois, United States, 60611
2
Elligo Health Research, Inc.
Austin, Texas, United States, 78738
3
Atlantia Food Clinical Trials
Cork, Ireland, T23 R50R