Ulcerative Colitis
Conditions
Keywords
Microbiome, Ulcerative Colitis, Kaleido, Kaleido Biosciences, KB295, Oligosaccharide, Glycan, Pathogens, Microbiome metabolic therapy, MMT, Mild-to-moderate UC
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
Interventions
OTHERKB295
KB295 is a novel glycan
Sponsors
Kaleido Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Ireland, United States
Outcome results
None listed