A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function

• KB295 (Other): KB295 is a novel glycan

Primary outcomes

• 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]

Sex: All, ages: 18 Years to 75 Years

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

• Mark Wingertzahn, PhD, Study director, Kaleido Biosciences