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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04893239
Registration number
NCT04893239
Ethics application status
Date submitted
14/05/2021
Date registered
19/05/2021
Date last updated
3/03/2022
Titles & IDs
Public title
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
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Scientific title
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
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Secondary ID [1]
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CDI01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
C. Diff. Infections
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - LMN-201
Other interventions: LMN-201
Components of LMN-201
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Presence or absence of capsules and/or transit markers in ostomy fluid by visual observation
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Assessment method [1]
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Presence or absence of capsules and/or transit markers in ostomy fluid by visual observation
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Timepoint [1]
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Up to 12 hours after dose
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Eligibility
Key inclusion criteria
- 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
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Minimum age
19
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Other
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/02/2022
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Sample size
Target
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Accrual to date
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Final
12
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Wesley Medical Research Limited - Auchenflower
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Recruitment hospital [2]
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Coastal Digestive Health - Maroochydore
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Recruitment hospital [3]
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Coral Sea Clinical Research Institute - North Mackay
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Recruitment postcode(s) [1]
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4066 - Auchenflower
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Recruitment postcode(s) [2]
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4558 - Maroochydore
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Recruitment postcode(s) [3]
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4740 - North Mackay
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Lumen Bioscience, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04893239
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04893239
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