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

NCT02865616 | Completed Phase 1 DMC

• 1 other identifier: MET-2-101
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clostridium Difficile Infection

Keywords

CDI; recurrent infection; MET-2; C. difficile

Outcome Measures

Primary Outcomes (1)

• To demonstrate clinical resolution of diarrhea with no CDI relapse,

  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.

  30 days

Secondary Outcomes (4)

• Incidence of adverse events (safety and tolerability)

  3 months

• number of bowel movements (overall well-being)

  3 months

• Presence of MET-2 bacteria

  30 days

• mortality

  3 months

Study Arms (1)

MET-2 Capsules

EXPERIMENTAL

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; Drug: Vancomycin

Interventions

MET-2 DRUG

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.

MET-2 Capsules

Vancomycin DRUG

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.

MET-2 Capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old.
• Able to provide informed consent, or have a caregiver able to provide consent
• Meets the definition of non-severe recurrent CDI (see Section 2.1, above) AND
• Has had a positive stool test for C. difficile within 60 days of enrolment
• Able to undergo colonoscopy and enemas
• Not pregnant
• 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

You may not qualify if:

• Life expectancy \< 6 months
• Evidence of severe CDI ((neutropenia (ANC\<1000) or WBC\>30, creatinine \>2X baseline, presence of toxic megacolon or intestinal perforation, admission to ICU)
• History of chronic diarrhea
• Need for regular use of agents that affect GI motility (narcotics such as codeine or morphine, agents such as loperamide or metoclopramide)
• Use of antibiotics for another infection (other than CDI)
• Colostomy
• Elective surgery that will require preoperative antibiotics planned within 6 months of enrolment
• Pregnant or planning to get pregnant in the next 6 months
• Unable to tolerate MET-2 for any reason
• Any condition for which colonoscopy or enema may be contraindicated (e.g., neutropenia, thrombocytopenia, bleeding disorders, severe colitis, etc)
• Any condition for which, in the opinion of the investigator, the patient should be excluded from the study.

Sponsors & Collaborators

• NuBiyota: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2X8, Canada

Location

Related Publications (1)

• Kao D, Wong K, Franz R, Cochrane K, Sherriff K, Chui L, Lloyd C, Roach B, Bai AD, Petrof EO, Allen-Vercoe E. The effect of a microbial ecosystem therapeutic (MET-2) on recurrent Clostridioides difficile infection: a phase 1, open-label, single-group trial. Lancet Gastroenterol Hepatol. 2021 Apr;6(4):282-291. doi: 10.1016/S2468-1253(21)00007-8. Epub 2021 Feb 23.

  PMID: 33631102 DERIVED

MeSH Terms

Conditions

Clostridium Infections; Reinfection

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Recurrence; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dina Kao, MD

  University of Alberta, Edmonton Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 12, 2016
• Study Start: October 27, 2017
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)