Status:
COMPLETED
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
Lead Sponsor:
Lumen Bioscience, Inc.
Conditions:
C. Diff. Infections
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04893239
Start Date
August 18 2021
End Date
February 23 2022
Last Update
March 18 2025
Active Locations (3)
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1
Wesley Medical Research Limited
Auchenflower, Queensland, Australia, 4066
2
Coastal Digestive Health
Maroochydore, Queensland, Australia, 4558
3
Coral Sea Clinical Research Institute
North Mackay, Queensland, Australia, 4740