Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: MET-1 Clinical Pilot Study for Recurrent C. Difficile

Summary: To measure the resolution of diarrhea as well as the feasibility of administration and safety of MET-1 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.

Detailed description: The primary endpoint is clinical resolution of diarrhea with no CDI relapse at 30 days following the last dose of MET-1, i.e., absence of recurrence of diarrheal symptoms (see definitions section) with laboratory-confirmed evidence of C. difficile after 30 days.
  The secondary endpoints 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 (see appendix); iii) presence of MET-1 bacteria in stool at 30 days, based on DNA sequencing; iv) mortality, at end of followup period - mortality attributable to CDI will also be determined, by performing a detailed clinical chart review on any patient who expires during the followup period.
  Open label, single center pilot study of 20 patients. Patients who have met the inclusion criteria will be given up to four doses administered within 12 days ± 5 days; the first two doses will be given by colonoscopy, and the third and fourth dose via enema only for patients that continue to have symptoms post treatment. Patients will be on vancomycin to control symptoms up until the time of the treatment. Patient must hold their po vancomycin for 24-48 hours prior to receiving the first dose. Patients will be followed up for 6 months post-treatment.

Eligibility: 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 recurrent CDI (see 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
  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 preop antibiotics planned within 6 months of enrolment
  8. Pregnant or planning to get pregnant in the next 6 months
  9. unable to tolerate MET-1 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.

Relevance to patient case: not relevant