Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD

This is an exploratory, Phase IIa, open-label study assessing the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 with 3 sequential groups of 10 patients with CDAD. Patients will be administered an oral dose of MGB-BP-3 for 10 days (Day 1 to Day 10). At the end of the treatment period, patients will be followed for up to 8 weeks to assess the incidence of disease recurrence.

Main Inclusion Criteria:

• Age 18 years or older of any gender.
• Inpatients and/or outpatients who are able to attend all scheduled visits.
• Patients with the first episode or the first recurrence of mild or moderate CDAD.
• Confirmed diagnosis of mild or moderate CDAD as defined by the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America guidelines.

Main Exclusion Criteria:

• Patients with severe complicated CDAD (including hypotension or shock, ileus, megacolon, pseudomembranous colitis).
• A white blood cell count higher than 15,000 cells/mL.
• A serum creatinine level greater than or equal to 1.5 times ULN.
• Elevated liver enzymes alanine aminotransferase and aspartate aminotransferase greater than ULN.
• Inflammatory bowel disease (ulcerative colitis or Crohn's disease), microscopic colitis, or irritable bowel syndrome with chronic diarrhea.
• Any other non-C difficile diarrhea.
• Received treatment with a fecal transplant within 7 days and/or is anticipated to receive a fecal transplant during the study.
• Major gastrointestinal surgery (ie, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).
• Received laxatives within the previous 48 hours.
• Pregnant or lactating women.
• Prior (within 180 days of Screening) or current use of anti-toxin antibodies.
• Have received a vaccine against C difficile.
• Any condition for which, in the opinion of the investigator, the treatment may pose a health risk to the patient.