Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04893239




Registration number
NCT04893239
Ethics application status
Date submitted
14/05/2021
Date registered
19/05/2021
Date last updated
3/03/2022

Titles & IDs
Public title
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
Scientific title
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
Secondary ID [1] 0 0
CDI01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
C. Diff. Infections 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - LMN-201

Treatment: Other: LMN-201
Components of LMN-201
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence or absence of capsules and/or transit markers in ostomy fluid by visual observation
Timepoint [1] 0 0
Up to 12 hours after dose

Eligibility
Key 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
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/02/2022
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Wesley Medical Research Limited - Auchenflower
Recruitment hospital [2] 0 0
Coastal Digestive Health - Maroochydore
Recruitment hospital [3] 0 0
Coral Sea Clinical Research Institute - North Mackay
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
4740 - North Mackay

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lumen Bioscience, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04893239
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04893239