Ulcerative ColitisNCT04508413
A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function
A study testing KB295 in people with Ulcerative Colitis, run by Kaleido Biosciences at 3 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- KB295
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 12 Aug 2020to 29 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Elligo Health Research, Inc.
Austin, Texas, 78738
Atlantia Food Clinical Trials
Chicago, Illinois, 60611
About this study
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
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
- Conditions
- Ulcerative Colitis
- Being tested
- KB295
- Keywords
- Microbiome, Ulcerative Colitis, Kaleido, Kaleido Biosciences, KB295, Oligosaccharide, Glycan, Pathogens, Microbiome metabolic therapy, MMT, Mild-to-moderate UC
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB295Other
KB295 is a novel glycan
| Study group | Role | What they receive |
|---|---|---|
| KB295 | Other | Not described Receives: Other: KB295 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing any treatment-emergent adverse events (TEAEs)
Measured: Day -1 to Day 84
Number of patients experiencing discontinuations due to adverse events (AEs)
Measured: Day -1 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start12 Aug 2020
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaleido Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Wingertzahn, PhD, Study director, Kaleido Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508413
- Sponsor's protocol ID
- K030-120
- Status last verified
- Jan 2022
- First submitted
- 7 Aug 2020
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04508413
- Acronym / sponsor ID
- K030-120
- Conditions
- Ulcerative Colitis
- Keywords
- Microbiome, Ulcerative Colitis, Kaleido, Kaleido Biosciences, KB295, Oligosaccharide, Glycan, Pathogens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kaleido BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KB295 | Other | Other: KB295 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KB295KB295 is a novel glycan | Other | KB295 |
Primary outcome
Number of patients experiencing any treatment-emergent adverse events (TEAEs)
Time frame: Day -1 to Day 84
Number of patients experiencing discontinuations due to adverse events (AEs)
Time frame: Day -1 to Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Wingertzahn, PhD study director
Kaleido Biosciences
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KB295 in people with Ulcerative Colitis, run by Kaleido Biosciences at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients experiencing any treatment-emergent adverse events (TEAEs) (time frame: Day -1 to Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.