Phase 1
Completed N=12
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
C. Diff. Infections
Source: ClinicalTrials.gov NCT04893239 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation — 0; 0; 0; 0 Participants
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.
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 | — |
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. Informational only — not medical advice.