Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT05330182

LMN-201 for Prevention of C. Difficile Infection Recurrence

Led by Lumen Bioscience, Inc. · Updated on 2026-02-10

375

Participants Needed

16

Research Sites

169 weeks

Total Duration

On this page

Sponsors

L

Lumen Bioscience, Inc.

Lead Sponsor

C

Congressionally Directed Medical Research Programs

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a multisite study to evaluate the safety, tolerability, and efficacy of LMN-201 in participants recently diagnosed with CDI who are scheduled to receive or are receiving SOC antibiotic therapy against C. difficile.

CONDITIONS

Official Title

LMN-201 for Prevention of C. Difficile Infection Recurrence

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Diagnosed with CDI defined by 3 or more loose or watery bowel movements per day and a positive stool C. difficile toxin B test within 7 days before first dose
  • Signed and dated informed consent provided
  • Scheduled to receive or planning to receive up to 28 days of standard antibiotic therapy for CDI (fidaxomicin, metronidazole, or vancomycin)
  • May be on systemic antibiotics for infections not related to the gastrointestinal tract
  • Able to take oral medication and willing to follow study medication schedule
  • Willing and able to comply with all study procedures and available for study duration
  • Access to a mobile smartphone
  • Females of reproductive potential must use effective contraception for 4 weeks before screening and during the study plus 4 weeks after
  • Males of reproductive potential must agree to use condoms or effective contraception during the study plus 4 weeks after
Not Eligible

You will not qualify if you...

  • Fulminant C. difficile colitis
  • Admitted or expected admission to intensive care unit
  • Underlying gastrointestinal disorders causing diarrhea such as chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome, pancreatic insufficiency, or enteric infections
  • Neutropenia with absolute neutrophil count below 1000 per microliter
  • Treatment within past 3 months with therapies affecting study outcomes (e.g., Bezlotoxumab, C. difficile vaccine, SER-109, CP101, VE303, fecal microbiota transplant, oral exchange resins, long-term mu-agonist opioids or anticholinergic medications for diarrhea)
  • Planned antibiotic therapy for CDI exceeding 28 days
  • Pregnancy, anticipated pregnancy, or breastfeeding
  • Unable or unwilling to swallow large capsules due to swallowing disorders
  • Conditions preventing capsule passage through digestive tract such as gastroparesis, vomiting, or anatomical narrowing
  • Psychiatric illness affecting compliance
  • Status as inmate, or resident in mental health or substance abuse programs
  • Terminal illness with life expectancy less than 24 weeks
  • Clinically significant co-morbid diseases making participation unsafe
  • Any other condition risking safety, compliance, or study integrity as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Kaiser Permanente

Escondido, California, United States, 90027

Actively Recruiting

2

Bridgeport Hospital

Bridgeport, Connecticut, United States, 06610

Actively Recruiting

3

Gastroenterology Center of Connecticut

Hamden, Connecticut, United States, 06518

Actively Recruiting

4

GI PROS Research

Naples, Florida, United States, 34102

Actively Recruiting

5

Metro Infectious Disease Consultants - Atlanta

Decatur, Georgia, United States, 30033

Actively Recruiting

6

Snake River Research

Idaho Falls, Idaho, United States, 83404

Actively Recruiting

7

Metro Infectious Disease Consultants, LLC

Burr Ridge, Illinois, United States, 60527

Actively Recruiting

8

DM Clinical Research

Oak Lawn, Illinois, United States, 60453

Actively Recruiting

9

Baptist Health Research

Lexington, Kentucky, United States, 40503

Actively Recruiting

10

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

11

Mercury Street Medical

Butte, Montana, United States, 59701

Actively Recruiting

12

Quality Clinical Research, Inc

Omaha, Nebraska, United States, 68114

Actively Recruiting

13

Weill Cornell Medicine

New York, New York, United States, 10021

Actively Recruiting

14

IMA Clinical Research

Mount Airy, North Carolina, United States, 27030

Actively Recruiting

15

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

16

Clinical Alliance for Infectious Diseases - Infectious Diseases, LLC

Annandale, Virginia, United States, 22003

Actively Recruiting

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Research Team

C

Carl Mason

CONTACT

A

Asa Davis

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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