Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
1 other identifier
interventional
12
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2021
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedStudy Start
First participant enrolled
August 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2022
CompletedResults Posted
Study results publicly available
March 18, 2025
CompletedMarch 18, 2025
February 1, 2025
6 months
May 14, 2021
February 7, 2025
February 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Arrival (baseline), Predose (immediately before dosing), and up to 12 hours post dose.
Study Arms (4)
Cohort 1 LMN-201 Anti-toxin B VHH-1
EXPERIMENTALCohort 1 LMN-201 Anti-toxin B VHH-2
EXPERIMENTALCohort 1 LMN-201 Anti-toxin B VHH-3
EXPERIMENTALCohort 4 LMN-201 VHH 1, 2, 3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Wesley Medical Research Limited
Auchenflower, Queensland, 4066, Australia
Coastal Digestive Health
Maroochydore, Queensland, 4558, Australia
Coral Sea Clinical Research Institute
North Mackay, Queensland, 4740, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Medical Director
- Organization
- Lumen Bioscience
Study Officials
- STUDY DIRECTOR
Carl Mason
Lumen Bioscience, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2021
First Posted
May 19, 2021
Study Start
August 18, 2021
Primary Completion
February 23, 2022
Study Completion
February 23, 2022
Last Updated
March 18, 2025
Results First Posted
March 18, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share