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

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ClinicalTrials.gov Identifier: NCT02865616
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
NuBiyota

Brief Summary:
MET-2 clinical study is an Open label, single center, multiple dose pilot study of 20 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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: MET-2 Drug: Vancomycin Phase 1

Detailed Description:

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 20 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 objectivesare: 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Single-Centre Study of the Safety and Efficacy of MET-2 in Patients With Recurrent Clostridium Difficile Infection (CDI)
Actual Study Start Date : October 27, 2017
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : February 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MET-2 Capsules

Patients will be on vancomycin to control symptoms up until the time of the treatment.

Initial Loading Dose: Patients will be given an initial daily loading dose of 5 g MET-2 over 2 days followed by a maintenance dose of 1.5 g over 8 days. Patients who do not experience treatment failure between Day 14 and Day 40 will be monitored until Day 130.

Second Loading Dose: Patients experiencing treatment failure after the first dose may be offered a second, higher loading dose 10 g of MET-2 in the form of 20 MET-2 capsules per day for two days, there will not be additional daily dosing beyond the first 10 days.

Colonoscopy: Patients failing the second loading dose of MET-2 may be offered 15 g of MET-2, equivalent to a 30 MET-2 capsule loading dose by weight, via colonoscopy..

All patients will be followed up for 120 days after the last treatment has been received.

Drug: MET-2
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.

Drug: Vancomycin
Patients will be on vancomycin to control symptoms up until the time of the treatment. Patient must hold their p.o. vancomycin for 24 hours prior to receiving the first dose.




Primary Outcome Measures :
  1. To demonstrate clinical resolution of diarrhea with no CDI relapse, [ Time Frame: 30 days ]
    To demonstrate clinical resolution of diarrhea with no CDI relapse at 30 days following the last dose of MET-2, the subject will undergo full physical examination including Blood Pressure, Heart rate and body temperature measurement. A blood test will be conducted with chemistry panel, and CBC with differential. Stool test and culture will also be conducted to measure the presence of C.difficile and DNA sequencing will determine the presence of MET-2 bacteria in the stool.


Secondary Outcome Measures :
  1. Incidence of adverse events (safety and tolerability) [ Time Frame: 3 months ]
    safety and tolerability, including adverse events of grade 2 or above

  2. number of bowel movements (overall well-being) [ Time Frame: 3 months ]
    overall well-being including number of bowel movements, etc as based on standardized IBS questionnaire

  3. Presence of MET-2 bacteria [ Time Frame: 30 days ]
    Presence of MET-2 bacteria in stool at 30 days, based on DNA sequencing

  4. mortality [ Time Frame: 3 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865616


Contacts
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Contact: Shawn Langer 917-626-3566 shawnlanger@gmail.com

Locations
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Canada, Ontario
Queen's University, Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 5G2
Contact: Mark Ropeleski, MD    613-544-3400 ext x2288    ropelesm@hdh.kari.net   
Sponsors and Collaborators
NuBiyota
Investigators
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Principal Investigator: Mark Ropeleski, MD Queen's University, Kingston General Hospital

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Responsible Party: NuBiyota
ClinicalTrials.gov Identifier: NCT02865616     History of Changes
Other Study ID Numbers: MET-2-101
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NuBiyota:
CDI
recurrent infection
MET-2
C. difficile

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents