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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04508413
Recruitment Status : Completed
First Posted : August 11, 2020
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
Kaleido Biosciences

Study Description
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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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: KB295 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : August 12, 2020
Actual Primary Completion Date : November 29, 2021
Actual Study Completion Date : November 29, 2021

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Arms and Interventions
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Arm Intervention/treatment
KB295 Other: KB295
KB295 is a novel glycan


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients experiencing any treatment-emergent adverse events (TEAEs) [ Time Frame: Day -1 to Day 84 ]
  2. Number of patients experiencing discontinuations due to adverse events (AEs) [ Time Frame: Day -1 to Day 84 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508413


Locations
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United States, Illinois
Atlantia Food Clinical Trials
Chicago, Illinois, United States, 60611
United States, Texas
Elligo Health Research, Inc.
Austin, Texas, United States, 78738
Ireland
Atlantia Food Clinical Trials
Cork, Ireland, T23 R50R
Sponsors and Collaborators
Kaleido Biosciences
Investigators
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Study Director: Mark Wingertzahn, PhD Kaleido Biosciences
More Information
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Responsible Party: Kaleido Biosciences
ClinicalTrials.gov Identifier: NCT04508413    
Other Study ID Numbers: K030-120
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaleido Biosciences:
Microbiome
Ulcerative Colitis
Kaleido
Kaleido Biosciences
KB295
Oligosaccharide
 Glycan
Pathogens
Microbiome metabolic therapy
MMT
Mild-to-moderate UC
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases