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

Not Applicable

Completed

• Conditions: Ulcerative Colitis
• Interventions: Other: KB295

• Registration Number: NCT04508413
• Lead Sponsor: Kaleido Biosciences

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-11
• Study Start: 2020-08-12
• Primary Completion: 2021-11-29
• Study Completion: 2021-11-29
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KB295	KB295	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Elligo Health Research, Inc.; 🇺🇸 Austin, Texas, United States

Atlantia Food Clinical Trials; 🇮🇪 Cork, Ireland