MET-2 Clinical Study for Recurrent Clostridium Difficile Infection (CDI)
MET-2 Clinical Study for Recurrent Clostridium Difficile Infection (CDI)
MET-2 clinical study is an Open label, single center, multiple dose pilot study of 19
 patients. The study is designed to measure the resolution of diarrhea as well as the
 feasibility of administration and safety of MET-2 for the treatment of recurrent CDI in
 patients who have experienced at least two prior episodes of CDI and have developed
 recurrence after having completed standard-of care oral antibiotic therapy to treat CDI.
Microbial Ecosystem Therapeutics (MET) is a new treatment approach for debilitating recurrent
 Clostridium difficile infection that has been developed as an alternative to fecal
 transplantation. This treatment is not a drug or biologic, but is comprised of live microbes
 that normally reside in the human gut of a healthy individual.The product is a defined
 microbial community derived from healthy donor stool, referred to as Microbial Ecosystem
 Therapeutic-2 (MET-2).

 In this open label, single center, multiple dose pilot study of 19 patients will be
 recruited. Patients will be given an initial daily loading dose of MET-2 over 2 days followed
 by a maintenance dose of MET-2 over 8 days. Patients experiencing treatment failure after the
 first dose may be offered a second, higher loading dose of MET-2. Patients failing the second
 loading dose of MET-2 may be offered a higher dose of MET-2 via colonoscopy.

 The primary objective is clinical resolution of diarrhea with no CDI relapse at 30 days
 following the last dose of MET-2, i.e., absence of recurrence of diarrheal symptoms with
 laboratory-confirmed evidence of C. difficile 30 days after last dose of treatment.

 The secondary objectives are: i) Safety and tolerability, including adverse events of grade 2
 or above; ii) Overall well-being including number of bowel movements and energy level, etc.
 as based on standardized IBS questionnaire; iii) Presence of MET-2 bacteria in stool at 30
 days, based on DNA sequencing; and, iv) Mortality, at end of follow up period - mortality
 attributable to CDI will also be determined, by performing a detailed clinical chart review
 on any patient who expires during the follow up period.
Inclusion Criteria:

 1. ≥ 18 years old.

 2. Able to provide informed consent, or have a caregiver able to provide consent

 3. Meets the definition of non-severe recurrent CDI (see Section 2.1, above) AND

 4. Has had a positive stool test for C. difficile within 60 days of enrolment

 5. Able to undergo colonoscopy and enemas

 6. Not pregnant

 7. Willing to participate in follow up as part of the study

 In addition, the patient must agree to undergo stool testing and blood screening tests that
 are part of the study, including hepatitis and HIV testing

 Exclusion Criteria:

 1. Life expectancy < 6 months

 2. Evidence of severe CDI ((neutropenia (ANC<1000) or WBC>30, creatinine >2X baseline,
 presence of toxic megacolon or intestinal perforation, admission to ICU)

 3. History of chronic diarrhea

 4. Need for regular use of agents that affect GI motility (narcotics such as codeine or
 morphine, agents such as loperamide or metoclopramide)

 5. Use of antibiotics for another infection (other than CDI)

 6. Colostomy

 7. Elective surgery that will require preoperative antibiotics planned within 6 months of
 enrolment

 8. Pregnant or planning to get pregnant in the next 6 months

 9. Unable to tolerate MET-2 for any reason

 10. Any condition for which colonoscopy or enema may be contraindicated (e.g.,
 neutropenia, thrombocytopenia, bleeding disorders, severe colitis, etc)

 11. Any condition for which, in the opinion of the investigator, the patient should be
 excluded from the study.