Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
Sponsor
Lumen Bioscience, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04893239
Collaborator
(none)
12
3
6.2
4
0.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
Actual Study Start Date
:
Aug 18, 2021
Actual Primary Completion Date
:
Feb 23, 2022
Actual Study Completion Date
:
Feb 23, 2022
Outcome Measures
Primary Outcome Measures
- Presence or absence of capsules and/or transit markers in ostomy fluid by visual observation [Up to 12 hours after dose]
Presence or absence of capsules and/or transit markers in ostomy fluid by visual observation
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
Sponsors and Collaborators
- Lumen Bioscience, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lumen Bioscience, Inc.
ClinicalTrials.gov Identifier:
NCT04893239
Other Study ID Numbers:
- CDI01
First Posted:
May 19, 2021
Last Update Posted:
Mar 3, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No