Phase 1
N=12
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
C. Diff. Infections
Bottom Line
View on ClinicalTrials.gov: NCT04893239 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LMN-201 Anti-toxin B VHH-1 (Biological); LMN-201 Anti-toxin B VHH-2 (Biological); LMN-201 Anti-toxin B VHH-3 (Biological); LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3 (Biological)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Lumen Bioscience, Inc.
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation |
0; 0; 0; 0; 0; 0 | — |
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 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
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
Data sourced from ClinicalTrials.gov (NCT04893239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.