LMN-201 for Prevention of C. Difficile Infection Recurrence
ConditionClostridioides Difficile Infection
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLumen Bioscience, Inc.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
LMN-201
DrugLMN-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
Placebo
DrugDoses of placebo will be delivered as identical-appearing cornstarch with coloring in size 00, white, opaque, capsules.
Treatment groups
375 Participants
are divided into 3 treatment groupsGroup A: Sentinel CohortExperimental treatment 1 intervention
Group B: LMN-201Active comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Up to 16 weeks after initiation of therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Lumen Bioscience, Inc.
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov