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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04508413
• Other study ID #: K030-120
• Status: Completed
• Phase: N/A
• Start date: August 12, 2020
• Est. completion date: November 29, 2021

Study information

• Verified date: January 2022
• Source: Kaleido Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• KB295
KB295 is a novel glycan

Locations

Country	Name	City	State
Ireland	Atlantia Food Clinical Trials	Cork
United States	Elligo Health Research, Inc.	Austin	Texas
United States	Atlantia Food Clinical Trials	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Kaleido Biosciences

Countries where clinical trial is conducted

United States,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients experiencing any treatment-emergent adverse events (TEAEs)		Day -1 to Day 84
Primary	Number of patients experiencing discontinuations due to adverse events (AEs)		Day -1 to Day 84