C. Diff. InfectionsPhase 1NCT04893239
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
A Phase 1 study testing LMN-201 Anti-toxin B VHH-1, LMN-201 Anti-toxin B VHH-2 and LMN-201 Anti-toxin B VHH-3 in people with C. Diff. Infections, run by Lumen Bioscience, Inc. at 3 sites in Australia.
Trial summary
This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- C. Diff. Infections
- What is being tested?
- LMN-201 Anti-toxin B VHH-1, LMN-201 Anti-toxin B VHH-2 and LMN-201 Anti-toxin B VHH-3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesAustralia
- Study dates
- 18 Aug 2021to 23 Feb 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to participate in the clinical trial
- Able and willing to provide informed consent
- Stable ostomy (no revisions in the last 6 months)
- At least 19 years old
- Medically stable, but may be on medications for chronic conditions
Who cannot join
- Unable or unwilling to provide adequate informed consent
- Non-English speakers
- Clinically significant disease
- Women who are pregnant, intending to become pregnant, or breastfeeding
- Use of anti-diarrheal medicine
- Suffer gastroparesis
- Opioid use
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Wesley Medical Research Limited
Auchenflower, Queensland, 4066
Coastal Digestive Health
Maroochydore, Queensland, 4558
Coral Sea Clinical Research Institute
North Mackay, Queensland, 4740
About this study
This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.
- Conditions
- C. Diff. Infections
- Being tested
- LMN-201 Anti-toxin B VHH-1, LMN-201 Anti-toxin B VHH-2, LMN-201 Anti-toxin B VHH-3, LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMN-201 Anti-toxin B VHH-1Biological
Components of LMN-201
LMN-201 Anti-toxin B VHH-2Biological
Components of LMN-201
LMN-201 Anti-toxin B VHH-3Biological
Components of LMN-201
LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3Biological
Components of LMN-201
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Experimental | Not described Receives: Biological: LMN-201 Anti-toxin B VHH-1 |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Experimental | Not described Receives: Biological: LMN-201 Anti-toxin B VHH-2 |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Experimental | Not described Receives: Biological: LMN-201 Anti-toxin B VHH-3 |
| Cohort 4 LMN-201 VHH 1, 2, 3 | Experimental | Not described Receives: Biological: LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
Count of participants with the presence or absence of capsules and/or transit markers at each collection timepoint in ostomy fluid by visual observation.
Measured: Arrival (baseline), Predose (immediately before dosing), and up to 12 hours post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start18 Aug 2021
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for C. Diff. InfectionsStudies 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumen Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl Mason, Study director, Lumen Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893239
- Sponsor's protocol ID
- CDI01
- Status last verified
- Feb 2025
- First submitted
- 14 May 2021
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
- ClinicalTrials.gov ID
- NCT04893239
- Acronym / sponsor ID
- CDI01
- Conditions
- C. Diff. Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lumen Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Experimental | Biological: LMN-201 Anti-toxin B VHH-1 |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Experimental | Biological: LMN-201 Anti-toxin B VHH-2 |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Experimental | Biological: LMN-201 Anti-toxin B VHH-3 |
| Cohort 4 LMN-201 VHH 1, 2, 3 | Experimental | Biological: LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing to participate in the clinical trial
- Able and willing to provide informed consent
- Stable ostomy (no revisions in the last 6 months)
- At least 19 years old
- Medically stable, but may be on medications for chronic conditions
Key exclusion criteria (7 listed)
- Unable or unwilling to provide adequate informed consent
- Non-English speakers
- Clinically significant disease
- Women who are pregnant, intending to become pregnant, or breastfeeding
- Use of anti-diarrheal medicine
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 |
|---|---|---|
| LMN-201 Anti-toxin B VHH-1Components of LMN-201 | Biological | Cohort 1 LMN-201 Anti-toxin B VHH-1 |
| LMN-201 Anti-toxin B VHH-2Components of LMN-201 | Biological | Cohort 1 LMN-201 Anti-toxin B VHH-2 |
| LMN-201 Anti-toxin B VHH-3Components of LMN-201 | Biological | Cohort 1 LMN-201 Anti-toxin B VHH-3 |
| LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3Components of LMN-201 | Biological | Cohort 4 LMN-201 VHH 1, 2, 3 |
Primary outcome
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
Time frame: Arrival (baseline), Predose (immediately before dosing), and up to 12 hours post dose.
Count of participants with the presence or absence of capsules and/or transit markers at each collection timepoint in ostomy fluid by visual observation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Carl Mason study director
Lumen Bioscience, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LMN-201 Anti-toxin B VHH-1, LMN-201 Anti-toxin B VHH-2 and LMN-201 Anti-toxin B VHH-3 in people with C. Diff. Infections, run by Lumen Bioscience, Inc. at 3 sites in Australia.
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 5 inclusion and 7 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 18 Mar 2025. 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 Australia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation (time frame: Arrival (baseline), Predose (immediately before dosing), and up to 12 hours post dose.). 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 18 Mar 2025.