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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Be male or female, ≥18 and ≤75 years of age - Be willing to give informed consent - Have a body mass index ≥18.5 and <45 kg/m2 - Confirmed diagnosis of UC (>6 months) by endoscopy - Mild-to-moderate UC with at least 4 weeks of UC symptoms prior to screening - Stable dose of oral mesalamine or purine analogs for at least 4 weeks prior to screening - Be willing to maintain a stable diet and continue taking the same regimen of supplements for the duration of the study - Female patients who are not pregnant and not trying to become pregnant or lactating

Exclusion Criteria:

- Possible or confirmed diagnosis of Crohn's disease - Prior medical history of isolated distal proctitis limited to the rectum due to IBD or other etiologies - Use of any antidiarrheal medications within the last 1 week prior to screening - Antibiotic treatment within the past 28 days prior to screening - Certain prior UC treatments (including biologics) as described in the protocol - Any immunosuppressive medications other than purine analog and no systemic corticosteroids - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04508413
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kaleido Biosciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mark Wingertzahn, PhD
Principal Investigator Affiliation Kaleido Biosciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Ireland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

Other: KB295

Interventions

Other: - KB295

KB295 is a novel glycan

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Atlantia Food Clinical Trials, Cork, Ireland

Status

Recruiting

Address

Atlantia Food Clinical Trials

Cork, , T23 R50R

Site Contact

Shauni Fitzgerald, BSc, MSc

sfitzgerald@atlantiafoodtrials.com

00353 21 430 7442

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