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

January 20, 2022 updated by: Kaleido Biosciences

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland, T23 R50R
        • Atlantia Food Clinical Trials
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Atlantia Food Clinical Trials
    • Texas
      • Austin, Texas, United States, 78738
        • Elligo Health Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: KB295
Other: KB295
KB295 is a novel glycan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients experiencing any treatment-emergent adverse events (TEAEs)
Time Frame: Day -1 to Day 84
Day -1 to Day 84
Number of patients experiencing discontinuations due to adverse events (AEs)
Time Frame: Day -1 to Day 84
Day -1 to Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaleido Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 12, 2020

Primary Completion (ACTUAL)

November 29, 2021

Study Completion (ACTUAL)

November 29, 2021

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (ACTUAL)

August 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K030-120

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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