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

Kaleido Biosciences

Status

Completed

Conditions

Ulcerative Colitis

Treatments

Other: KB295

Study type

Interventional

Funder types

Industry

Identifiers

NCT04508413

K030-120

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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