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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

LMN-201 for Prevention of C. Difficile Infection Recurrence

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

LMN-201 for Prevention of C. Difficile Infection Recurrence (NCT05330182) is a Phase 2 / Phase 3 interventional studying Clostridioides Difficile Infection, sponsored by Lumen Bioscience, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Clostridioides Difficile Infection and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 375 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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. Who Should NOT Join This Trial: 1. Fulminant C. difficile colitis. 2. Admitted or expect to be admitted to an intensive care unit. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion 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. Exclusion Criteria: 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.

Treatments Being Tested

DRUG

LMN-201

LMN-201 consists of orally delivered whole, dried, non-viable biomass of spirulina (Arthrospira platensis) grown from 4 separate strains, each of which has been engineered to express one of the following therapeutic proteins: * 3 toxin-binding proteins that bind and inhibit C. difficile toxin B (TcdB), an essential virulence factor for C. difficile * 1 lysozyme-like enzyme that selectively degrades the cell wall of C. difficile and causes rapid destruction of the organism

DRUG

Placebo

Doses of placebo will be delivered as identical-appearing cornstarch with coloring in size 00, white, opaque, capsules.

Locations (16)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Kaiser Permanente
Escondido, California, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Gastroenterology Center of Connecticut
Hamden, Connecticut, United States
GI PROS Research
Naples, Florida, United States
Metro Infectious Disease Consultants - Atlanta
Decatur, Georgia, United States
Snake River Research
Idaho Falls, Idaho, United States
Metro Infectious Disease Consultants, LLC
Burr Ridge, Illinois, United States
DM Clinical Research
Oak Lawn, Illinois, United States
Baptist Health Research
Lexington, Kentucky, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mercury Street Medical
Butte, Montana, United States
Quality Clinical Research, Inc
Omaha, Nebraska, United States
Weill Cornell Medicine
New York, New York, United States
IMA Clinical Research
Mount Airy, North Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Clinical Alliance for Infectious Diseases - Infectious Diseases, LLC
Annandale, Virginia, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05330182), the sponsor (Lumen Bioscience, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05330182 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05330182?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05330182?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05330182. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05330182. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.