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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-12

Study Completion Date

2021-11-29

Brief Summary

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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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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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KB295

Group Type OTHER

KB295

Intervention Type OTHER

KB295 is a novel glycan

Interventions

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KB295

KB295 is a novel glycan

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No