NCT02865616 is a Phase 1 clinical trial of MET-2 in Clostridium Difficile Infection, sponsored by NuBiyota.

Who is sponsoring NCT02865616?

NCT02865616 is sponsored by NuBiyota.

What drugs are being tested in NCT02865616?

Interventions in NCT02865616: MET-2, Vancomycin.

What condition does NCT02865616 study?

NCT02865616 studies Clostridium Difficile Infection.

Is NCT02865616 still recruiting?

NCT02865616 is currently completed. Last updated 11 August 2020.

Last reviewed 2020-08-11 · How we verify

NCT02865616

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 11 August 2020

What this trial tests

Phase 1 trial testing MET-2 in Clostridium Difficile Infection in 19 participants. Completed in 17 March 2020.

Timeline

27 October 2017

Primary endpoint
17 March 2020

17 March 2020

Quick facts

Lead sponsor	NuBiyota
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	27 October 2017
Primary completion	17 March 2020
Estimated completion	17 March 2020
Sites	1 location across Canada

Drugs / interventions tested

MET-2 — full drug profile →
Vancomycin (vancomycin) — full drug profile →

Conditions studied

Clostridium Difficile Infection — all drugs for Clostridium Difficile Infection →

Sponsor

NuBiyota — full company profile →

Who can join

18 and older, any sex, with Clostridium Difficile Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The effect of a microbial ecosystem therapeutic (MET-2) on recurrent Clostridioides difficile infection: a phase 1, open-label, single-group trial.
Kao D, Wong K, Franz R, Cochrane K, et al · · 2021 · cited 68× · PMID 33631102 · DOI 10.1016/s2468-1253(21)00007-8
Novel therapies and preventative strategies for primary and recurrent Clostridium difficile infections.
Dieterle MG, Rao K, Young VB. · · 2019 · cited 44× · PMID 30238983 · DOI 10.1111/nyas.13958
Microbial therapeutics: New opportunities for drug delivery.
Jimenez M, Langer R, Traverso G. · · 2019 · cited 43× · PMID 31028093 · DOI 10.1084/jem.20190609
The role of the microbiome in gastrointestinal inflammation.
Sanders DJ, Inniss S, Sebepos-Rogers G, Rahman FZ, et al · · 2021 · cited 41× · PMID 34076695 · DOI 10.1042/bsr20203850
The Urgent Threat of Clostridioides difficile Infection: A Glimpse of the Drugs of the Future, with Related Patents and Prospects.
Alshrari AS, Hudu SA, Elmigdadi F, Imran M. · · 2023 · cited 17× · PMID 36830964 · DOI 10.3390/biomedicines11020426
The regulatory framework for microbiome-based therapies: insights into European regulatory developments.
Rodriguez J, Cordaillat-Simmons M, Pot B, Druart C. · · 2025 · cited 13× · PMID 40155609 · DOI 10.1038/s41522-025-00683-0
Safety of fecal microbiota transplantation for Clostridioides difficile infection focusing on pathobionts and SARS-CoV-2.
Yadav D, Khanna S. · · 2021 · cited 10× · PMID 33959193 · DOI 10.1177/17562848211009694
Microbiota-Based Live Biotherapeutic Products for Clostridioides Difficile Infection- The Devil is in the Details.
Monday L, Tillotson G, Chopra T. · · 2024 · cited 9× · PMID 38375101 · DOI 10.2147/idr.s419243

Verify or expand the search:

Other trials of MET-2

Trials testing the same drug.

NCT04052451 — The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Gener · Phase 1 · completed
NCT03832400 — Safety and Efficacy of Microbial Ecosystem Therapeutic-2 (MET-2) in Patients With Ulcerative Colitis (UC) · Phase 1 · completed
NCT03660748 — Safety and Efficacy of MET-3 in Obese Human Subjects · EARLY_PHASE1 · completed

Other recruiting trials for Clostridium Difficile Infection

Currently open trials in the same condition.

NCT07221370 — Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients · Phase 2, PHASE3 · recruiting
NCT06703918 — Study on Clostridium Difficile Infection in Infants · recruiting
NCT04305769 — Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT) · Phase 2 · recruiting
NCT04014413 — Safety and Efficacy of Fecal Microbiota Transplantation · NA · recruiting
NCT03562741 — Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile · NA · recruiting

Other NuBiyota trials

Trials by the same sponsor.

NCT04507971 — Effects of MET-3 and MET-5 on Gut Microbiome and Metabolic Function in Men and Women With Hypertriglyceridemia · Phase 1 · unknown
NCT04052451 — The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Gener · Phase 1 · completed
NCT03832400 — Safety and Efficacy of Microbial Ecosystem Therapeutic-2 (MET-2) in Patients With Ulcerative Colitis (UC) · Phase 1 · completed
NCT03660748 — Safety and Efficacy of MET-3 in Obese Human Subjects · EARLY_PHASE1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02865616 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NuBiyota
Last refreshed: 11 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02865616.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing