Clinical Trials

Inclusion Criteria:

• Able to provide signed and dated informed consent

• Males and females between 18 - 75 years old inclusive

• Documented history of first recurrent Clostridiodides difficile (former Clostridium difficile) infection (rCDI), confirmed by a positive C. difficile test (Toxin A+B positive or Toxin B only), with initial infection occurring within the previous 12-months.

• Must, in accordance with standard of care practices, have completed a SOC oral antibiotic therapy for the first rCDI no more than 5 days prior to the date of enrolment (baseline visit- Day 0).

• Must not have any CDI-related symptoms when enrolled in the study at baseline (Day 0).

Exclusion Criteria:

• Current episode of CDI or delayed symptom resolution from previous recurrence, according to the physical exam and investigator assessment  

• Toxin A positive, and Toxin B negative C. difficile test.

• Planned CDI recurrence treatment for the duration of the study e.g., fecal microbiome transplant, probiotics, Live Biotherapeutic Products (LBPs)

• Those who are on further antibiotic treatment following initial rCDI antibiotic therapy completion.

• Pregnant or lactating women or women who intend to become pregnant within the next 3 months.

• Subjects presenting with active diarrhoea (3 or more stools per 24-hour period) and within Bristol stool scale range of 5-7 at baseline.

• Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.

  • Ostomized participants, parenteral nutrition users

  • Patients with active Pancreatitis

  • Active, non-controlled intestinal diseases such as IBS, IBD, Crohn's Disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness

• Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.

• Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/23/2025. Questions regarding updates should be directed to the study team contact.