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

Status Completed

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02865616
Study type	Interventional
Source	NuBiyota
Contact
Status	Completed
Phase	Phase 1
Start date	October 27, 2017
Completion date	March 17, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02214771` - Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients	N/A
Withdrawn	`NCT01552668` - Fidaxomicin to Prevent Clostridium Difficile Colonization	Phase 4
Recruiting	`NCT03325855` - Fecal Microbiota Transplant National Registry
Not yet recruiting	`NCT03586206` - Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
Recruiting	`NCT03350711` - A Screening and Recruitment Study in Adults Expressing Interest in the Emory Microbiota Enrichment Program
Withdrawn	`NCT03643887` - Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients	Phase 2
Terminated	`NCT04000555` - Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)	Phase 4
Terminated	`NCT03065374` - Treatment for Clostridium-difficile Infection With IMM529	Phase 1/Phase 2
Completed	`NCT03710694` - Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)	N/A
Recruiting	`NCT04940468` - High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology	N/A
Completed	`NCT02589847` - Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection	Phase 2
Not yet recruiting	`NCT01942447` - Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis	N/A
Active, not recruiting	`NCT02086916` - Novel Biomarkers to Predict Outcome in Clostridium Difficile Infection	N/A
Completed	`NCT01230957` - Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults	Phase 2
Completed	`NCT01241552` - A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)	Phase 3
Not yet recruiting	`NCT04567134` - Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
Completed	`NCT04075422` - Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
Recruiting	`NCT03712722` - Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
Recruiting	`NCT05192148` - Seroprevalence of Antibodies to Surface Antigens and Toxins of Clostridioides Difficile	N/A
Completed	`NCT02951702` - Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics	Phase 4