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

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

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