MET-2 Clinical Study for Recurrent Clostridium Difficile Infection (CDI)

• Status: Completed
• Trial end date: 2020-03-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NuBiyota
• Treatments: Vancomycin

Criteria

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.