A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function
Completed · Not applicable
Conditions studied: Ulcerative Colitis
In brief
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
Key facts
- Study ID
- NCT04508413
- Run by
- Kaleido Biosciences
- People needed
- 12
- Starts
- 2020-08-12
- Expected to finish
- 2021-11-29
- Last updated by the study team
- 2022-01-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Atlantia Food Clinical Trials — Chicago, Illinois, United States
- Elligo Health Research, Inc. — Austin, Texas, United States
- Atlantia Food Clinical Trials — Cork, Ireland
Full record on ClinicalTrials.gov
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