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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04893239
Recruitment Status : Completed
First Posted : May 19, 2021
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
C. Diff. Infections Biological: LMN-201 Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : August 18, 2021
Actual Primary Completion Date : February 23, 2022
Actual Study Completion Date : February 23, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy


Intervention Details:
  • Biological: LMN-201
    Components of LMN-201


Primary Outcome Measures :
  1. Presence or absence of capsules and/or transit markers in ostomy fluid by visual observation [ Time Frame: Up to 12 hours after dose ]
    Presence or absence of capsules and/or transit markers in ostomy fluid by visual observation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04893239


Locations
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Australia, Queensland
Wesley Medical Research Limited
Auchenflower, Queensland, Australia, 4066
Coastal Digestive Health
Maroochydore, Queensland, Australia, 4558
Coral Sea Clinical Research Institute
North Mackay, Queensland, Australia, 4740
Sponsors and Collaborators
Lumen Bioscience, Inc.
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Responsible Party: Lumen Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT04893239    
Other Study ID Numbers: CDI01
First Posted: May 19, 2021    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No