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OpenTrials
Completed

NCT Number: NCT04508413

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

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlantia Food Clinical Trials, Cork, Ireland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KB295

Other

KB295 is a novel glycan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kaleido Biosciences

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2020
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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