Back to resultsA Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
KB295
Sponsored by
About this trial
This is an interventional other trial for Ulcerative Colitis focused on measuring Microbiome, Ulcerative Colitis, Kaleido, Kaleido Biosciences, KB295, Oligosaccharide, Glycan, Pathogens, Microbiome metabolic therapy, MMT, Mild-to-moderate UC
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Atlantia Food Clinical Trials
- Elligo Health Research, Inc.
- Atlantia Food Clinical Trials
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
KB295
Arm Description
Outcomes
Primary Outcome Measures
Number of patients experiencing any treatment-emergent adverse events (TEAEs)
Number of patients experiencing discontinuations due to adverse events (AEs)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04508413
Brief Title
A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
November 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaleido Biosciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Microbiome, Ulcerative Colitis, Kaleido, Kaleido Biosciences, KB295, Oligosaccharide, Glycan, Pathogens, Microbiome metabolic therapy, MMT, Mild-to-moderate UC
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KB295
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
KB295
Intervention Description
KB295 is a novel glycan
Primary Outcome Measure Information:
Title
Number of patients experiencing any treatment-emergent adverse events (TEAEs)
Time Frame
Day -1 to Day 84
Title
Number of patients experiencing discontinuations due to adverse events (AEs)
Time Frame
Day -1 to Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Wingertzahn, PhD
Organizational Affiliation
Kaleido Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Atlantia Food Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Elligo Health Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78738
Country
United States
Facility Name
Atlantia Food Clinical Trials
City
Cork
ZIP/Postal Code
T23 R50R
Country
Ireland
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function
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