Clostridioides Difficile InfectionPhase 2/3NCT05330182
LMN-201 for Prevention of C. Difficile Infection Recurrence
A Phase 2/3 study testing LMN-201 in people with Clostridioides Difficile Infection, run by Lumen Bioscience, Inc. at 15 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridioides Difficile Infection
- What is being tested?
- LMN-201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 15 sitesUnited States
- Study dates
- 29 Aug 2024to 1 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 or older.
- 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.
- Provision of signed and dated informed consent form.
- 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)
- May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract.
- Ability to take oral medication and willingness to adhere to the study medication regimen.
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- 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.
- Access to a mobile smartphone.
- 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.
- 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 cannot join
- Fulminant C. difficile colitis.
- Admitted or expect to be admitted to an intensive care unit.
- 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.).
- Neutropenia (absolute neutrophil count of < 1000 per microliter for any reason).
- 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:
- Bezlotoxumab (Zinplava, Merck \& Co.), or another antibody against C. difficile toxin(s)
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- C. difficile vaccine
- SER-109 (Seres Therapeutics)
- CP101 (Finch Therapeutics)
- VE303 (Vedanta Therapeutics)
- Fecal microbiota transplant
- Current therapy with oral exchange resins
- 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.)
- Treatment with SOC antibiotic therapy is planned for longer than a 28-day period.
- Pregnancy, anticipated pregnancy, or breastfeeding.
- Inability or unwillingness to swallow numerous, relatively large capsules containing study drug or placebo because of a swallowing disorder or dysphagia.
- 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.
- Psychiatric illness that would affect compliance with medications, study capsules, or follow-up.
- Status as an inmate, residential mental health program, or residential substance abuse program.
- Terminal illness with limited life expectancy of less than 24 weeks.
- Poor concurrent medical risks with clinically significant co-morbid disease such that, in the opinion of the investigator, the patient should not be enrolled.
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Clinical Alliance for Infectious Diseases - Infectious Diseases, LLC
Annandale, Virginia, 22003
Metro Infectious Disease Consultants, LLC
Burr Ridge, Illinois, 60527
University of Virginia School of Medicine
Charlottesville, Virginia, 22903
Henry Ford Health System
Detroit, Michigan, 48202
Kaiser Permanente
Escondido, California, 90027
Gastroenterology Center of Connecticut
Hamden, Connecticut, 06518
MD Anderson Cancer Center
Houston, Texas, 77030
Baptist Health Research
Lexington, Kentucky, 40503
UW Health University Hospital
Madison, Wisconsin, 53792
University of Minnesota
Minneapolis, Minnesota, 55455
IMA Clinical Research
Mount Airy, North Carolina, 27030
Weill Cornell Medicine
New York, New York, 10021
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Kaiser Permanente-Mid Atlantic
Springfield, Virginia, 22015
University of South Florida
Tampa, Florida, 33606
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of LMN-201 for Prevention of C. Difficile Infection Recurrence
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
- Clostridioides Difficile Infection
- Being tested
- LMN-201, Placebo
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMN-201Drug
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
PlaceboDrug
Doses of placebo will be delivered as identical-appearing cornstarch with coloring in size 00, white, opaque, capsules.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Cohort | Experimental | Not described Receives: Drug: LMN-201 |
| LMN-201 | Active comparator | Not described Receives: Drug: LMN-201 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who achieve global cure
Proportion of total participants with both successful initial CDI treatment and no CDI recurrence during the Prevention and Observation Phases (by treatment assignment).
Measured: Up to 16 weeks after initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start29 Aug 2024
- Primary completion31 Aug 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumen Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330182
- Sponsor's protocol ID
- CDI02
- Other IDs
- CDMRP-PR221885
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Study of LMN-201 for Prevention of C. Difficile Infection Recurrence
- ClinicalTrials.gov ID
- NCT05330182
- Acronym / sponsor ID
- CDI02
- Conditions
- Clostridioides Difficile Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Lumen Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sentinel Cohort | Experimental | Drug: LMN-201 |
| LMN-201 | Active comparator | Drug: LMN-201 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, aged 18 or older.
- 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.
- Provision of signed and dated informed consent form.
- 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)
- May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract.
Key exclusion criteria (24 listed)
- Fulminant C. difficile colitis.
- Admitted or expect to be admitted to an intensive care unit.
- 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.).
- Neutropenia (absolute neutrophil count of < 1000 per microliter for any reason).
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMN-201LMN-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 | LMN-201, Sentinel Cohort |
| PlaceboDoses of placebo will be delivered as identical-appearing cornstarch with coloring in size 00, white, opaque, capsules. | Drug | Placebo |
Primary outcome
Proportion of participants who achieve global cure
Time frame: Up to 16 weeks after initiation of therapy
Proportion of total participants with both successful initial CDI treatment and no CDI recurrence during the Prevention and Observation Phases (by treatment assignment).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing LMN-201 in people with Clostridioides Difficile Infection, run by Lumen Bioscience, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who achieve global cure (time frame: Up to 16 weeks after initiation of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.