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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-18

Study Completion Date

2022-02-23

Brief Summary

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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.

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Detailed Description

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Conditions

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C. Diff. Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Components of LMN-201

Intervention Type BIOLOGICAL

LMN-201 Anti-toxin B VHH-2

Components of LMN-201

Intervention Type BIOLOGICAL

LMN-201 Anti-toxin B VHH-3

Components of LMN-201

Intervention Type BIOLOGICAL

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

Components of LMN-201

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes