Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies

C. Diff. Infections Clinical Trial

Official title:

Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04893239
• Other study ID #: CDI01
• Status: Completed
• Phase: Phase 1
• Start date: August 18, 2021
• Est. completion date: February 23, 2022

Study information

• Verified date: March 2022
• Source: Lumen Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• C. Diff. Infections

Intervention

Biological:
• LMN-201
Components of LMN-201

Locations

Country	Name	City	State
Australia	Wesley Medical Research Limited	Auchenflower	Queensland
Australia	Coastal Digestive Health	Maroochydore	Queensland
Australia	Coral Sea Clinical Research Institute	North Mackay	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Lumen Bioscience, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of capsules and/or transit markers in ostomy fluid by visual observation	Presence or absence of capsules and/or transit markers in ostomy fluid by visual observation	Up to 12 hours after dose