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

Phase 1

Completed

• Conditions: C. Diff. Infections
• Interventions: Biological: 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

• Registration Number: NCT04893239
• Lead Sponsor: Lumen Bioscience, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-14
• Study First Submitted QC: 2021-05-14
• Study First Posted: 2021-05-19
• Study Start: 2021-08-18
• Primary Completion: 2022-02-23
• Study Completion: 2022-02-23
• Status Verified: 2025-02
• Results First Submitted: 2025-02-07
• Results First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Results First Posted: 2025-03-18
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1 LMN-201 Anti-toxin B VHH-1	LMN-201 Anti-toxin B VHH-1	-
Cohort 1 LMN-201 Anti-toxin B VHH-2	LMN-201 Anti-toxin B VHH-2	-
Cohort 1 LMN-201 Anti-toxin B VHH-3	LMN-201 Anti-toxin B VHH-3	-
Cohort 4 LMN-201 VHH 1, 2, 3	LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3	-

Primary Outcome Measures

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

Trial Locations

Locations (3)

Coral Sea Clinical Research Institute; 🇦🇺 North Mackay, Queensland, Australia

Coastal Digestive Health; 🇦🇺 Maroochydore, Queensland, Australia

Wesley Medical Research Limited; 🇦🇺 Auchenflower, Queensland, Australia