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

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.

Completed

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Key information

Conditions

C. Diff. Infections Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wesley Medical Research Limited, Auchenflower, Queensland, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LMN-201 Anti-toxin B VHH-1

Biological

Components of LMN-201

LMN-201 Anti-toxin B VHH-2

Biological

Components of LMN-201

LMN-201 Anti-toxin B VHH-3

Biological

Components of LMN-201

LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3

Biological

Components of LMN-201

Primary outcomes

Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation

Time frame: Arrival (baseline), Predose (immediately before dosing), and up to 12 hours post dose.

Count of participants with the presence or absence of capsules and/or transit markers at each collection timepoint in ostomy fluid by visual observation.

Sponsors and collaborators

Lead sponsor

Lumen Bioscience, Inc.

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: May 19, 2021
Registry last updated: Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed