RECRUITING

LMN-201 for Prevention of C. Difficile Infection Recurrence

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of LMN-201 for Prevention of C. Difficile Infection Recurrence

Quick Facts

Study Start:2024-08-29

Study Completion:2026-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05330182

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female, aged 18 or older. 2. Diagnosis of CDI defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency (Bristol Stool Scale 5, 6, or 7); a positive stool C. difficile toxin B immunoassay (stool collected no more than 7 days before first dose of LMN-201/placebo), and no other likely explanation for diarrhea. NOTE: Diarrhea is not required to be present on the day of enrollment. 3. Provision of signed and dated informed consent form. 4. Scheduled to receive or planning to receive a ≤28-day course of SOC antibiotic therapy for CDI. Participant must have been diagnosed with CDI for 7 or fewer days at time of initial study drug administration. SOC antibiotic therapy is defined as the receipt of oral fidaxomicin or oral metronidazole or oral vancomycin (see Section 8.2.6) 5. May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract. 6. Ability to take oral medication and willingness to adhere to the study medication regimen. 7. Stated willingness and ability to comply with all study procedures and availability for the duration of the study and investigator believes individual will complete the study. 8. Access to a mobile smartphone. 9. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration. 10. For males of reproductive potential: agreement to use condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of study drug administration.	1. Fulminant C. difficile colitis. 2. Admitted or expect to be admitted to an intensive care unit. 3. Underlying gastrointestinal disorder characterized by diarrhea including but not limited to chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy, pancreatic insufficiency, enteric parasitic infection, viral enteritis, bacterial enteritis (salmonella, shigella, ETEC, etc.). 4. Neutropenia (absolute neutrophil count of \< 1000 per microliter for any reason). 5. Current or previous treatment in past 3 months with any therapy likely to influence the outcome of this study, including but not limited to the following: 1. Bezlotoxumab (Zinplava, Merck \& Co.), or another antibody against C. difficile toxin(s) 2. C. difficile vaccine 3. SER-109 (Seres Therapeutics) 4. CP101 (Finch Therapeutics) 5. VE303 (Vedanta Therapeutics) 6. Fecal microbiota transplant 7. Current therapy with oral exchange resins 8. Protracted exposure to mu-agonist opioids and/or anticholinergic medication prescribed for diarrheal symptoms (unable to stop mu-agonist opioid treatment unless on a stable dose as of onset of diarrhea and no increase in dose planned for the duration of the study.) 6. Treatment with SOC antibiotic therapy is planned for longer than a 28-day period. 7. Pregnancy, anticipated pregnancy, or breastfeeding. 8. Inability or unwillingness to swallow numerous, relatively large capsules containing study drug or placebo because of a swallowing disorder or dysphagia. 9. Inability to pass swallowed capsules into the distal small intestine because of gastroparesis, repetitive vomiting, or anatomic narrowing in the esophagus, stomach, or small intestine. 10. Psychiatric illness that would affect compliance with medications, study capsules, or follow-up. 11. Status as an inmate, residential mental health program, or residential substance abuse program. 12. Terminal illness with limited life expectancy of less than 24 weeks. 13. Poor concurrent medical risks with clinically significant co-morbid disease such that, in the opinion of the investigator, the patient should not be enrolled. 14. Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the individual, would make it unlikely for the individual to complete the study, or would confound the results of the study. * Note: Use of probiotics and other food supplements (e.g., yogurt, kefir, kimchi, etc.) are not exclusionary. * Note: Assuming participants meet all of the inclusion criteria and none of the exclusion criteria, participants with underlying malignancy with a good life expectancy in the study are not excluded.

Inclusion Criteria

Exclusion Criteria

1. Male or female, aged 18 or older.
2. Diagnosis of CDI defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency (Bristol Stool Scale 5, 6, or 7); a positive stool C. difficile toxin B immunoassay (stool collected no more than 7 days before first dose of LMN-201/placebo), and no other likely explanation for diarrhea. NOTE: Diarrhea is not required to be present on the day of enrollment.
3. Provision of signed and dated informed consent form.
4. Scheduled to receive or planning to receive a ≤28-day course of SOC antibiotic therapy for CDI. Participant must have been diagnosed with CDI for 7 or fewer days at time of initial study drug administration. SOC antibiotic therapy is defined as the receipt of oral fidaxomicin or oral metronidazole or oral vancomycin (see Section 8.2.6)
5. May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract.
6. Ability to take oral medication and willingness to adhere to the study medication regimen.
7. Stated willingness and ability to comply with all study procedures and availability for the duration of the study and investigator believes individual will complete the study.
8. Access to a mobile smartphone.
9. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration.
10. For males of reproductive potential: agreement to use condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of study drug administration.

1. Fulminant C. difficile colitis.
2. Admitted or expect to be admitted to an intensive care unit.
3. Underlying gastrointestinal disorder characterized by diarrhea including but not limited to chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy, pancreatic insufficiency, enteric parasitic infection, viral enteritis, bacterial enteritis (salmonella, shigella, ETEC, etc.).
4. Neutropenia (absolute neutrophil count of \< 1000 per microliter for any reason).
5. Current or previous treatment in past 3 months with any therapy likely to influence the outcome of this study, including but not limited to the following:
1. Bezlotoxumab (Zinplava, Merck \& Co.), or another antibody against C. difficile toxin(s)
2. C. difficile vaccine
3. SER-109 (Seres Therapeutics)
4. CP101 (Finch Therapeutics)
5. VE303 (Vedanta Therapeutics)
6. Fecal microbiota transplant
7. Current therapy with oral exchange resins
8. Protracted exposure to mu-agonist opioids and/or anticholinergic medication prescribed for diarrheal symptoms (unable to stop mu-agonist opioid treatment unless on a stable dose as of onset of diarrhea and no increase in dose planned for the duration of the study.)
6. Treatment with SOC antibiotic therapy is planned for longer than a 28-day period.
7. Pregnancy, anticipated pregnancy, or breastfeeding.
8. Inability or unwillingness to swallow numerous, relatively large capsules containing study drug or placebo because of a swallowing disorder or dysphagia.
9. Inability to pass swallowed capsules into the distal small intestine because of gastroparesis, repetitive vomiting, or anatomic narrowing in the esophagus, stomach, or small intestine.
10. Psychiatric illness that would affect compliance with medications, study capsules, or follow-up.
11. Status as an inmate, residential mental health program, or residential substance abuse program.
12. Terminal illness with limited life expectancy of less than 24 weeks.
13. Poor concurrent medical risks with clinically significant co-morbid disease such that, in the opinion of the investigator, the patient should not be enrolled.
14. Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the individual, would make it unlikely for the individual to complete the study, or would confound the results of the study.
* Note: Use of probiotics and other food supplements (e.g., yogurt, kefir, kimchi, etc.) are not exclusionary.
* Note: Assuming participants meet all of the inclusion criteria and none of the exclusion criteria, participants with underlying malignancy with a good life expectancy in the study are not excluded.

Contacts and Locations

Study Contact

Carl Mason

CONTACT

12068991904

trials@lumen.bio

Asa Davis

CONTACT

12068991904

trials@lumen.bio

Study Locations (Sites)

Kaiser Permanente

Los Angeles, California, 90027

United States

Bridgeport Hospital

Bridgeport, Connecticut, 06610

United States

Gastroenterology Center of Connecticut

Hamden, Connecticut, 06518

United States

GI PROS Research

Naples, Florida, 34102

United States

Metro Infectious Disease Consultants - Atlanta

Decatur, Georgia, 30033

United States

Snake River Research

Idaho Falls, Idaho, 83404

United States

Metro Infectious Disease Consultants, LLC

Burr Ridge, Illinois, 60527

United States

DM Clinical Research

Oak Lawn, Illinois, 60453

United States

Baptist Health Research

Lexington, Kentucky, 40503

United States

Mercury Street Medical

Butte, Montana, 59701

United States

Weill Cornell Medicine

New York, New York, 10021

United States

IMA Clinical Research

Mount Airy, North Carolina, 27030

United States

Clinical Trials Network

Mentor, Ohio, 44060

United States

Clinical Alliance for Infectious Diseases - Infectious Diseases, LLC

Annandale, Virginia, 22003

United States

Collaborators and Investigators

Sponsor: Lumen Bioscience, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-29

Study Completion Date2026-04-01

Study Record Updates

Study Start Date2024-08-29

Study Completion Date2026-04-01

Terms related to this study

Additional Relevant MeSH Terms

Clostridioides Difficile Infection