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Gut bacteria cocktail aimed at superbug infections – trial pulled before start

NCT ID NCT06214403

Disease control Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study planned to test a treatment called MET-2, a mix of gut bacteria, to help clear antibiotic-resistant germs from the body after a bloodstream infection. It was designed for adults not in intensive care who had a resistant infection. The trial was withdrawn before enrolling anyone, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult (≥18 years old) inpatient not admitted to the ICU or equivalent (step-up and step-down units are eligible) 2. Positive blood culture with an ARO: * AmpC beta-lactamase producing species: Enterobacter cloacae, Citrobacter spp., Klebsiella aerogenes, Serratia spp., Morganella morganii, Hafnia alvei OR * ESBL-producing gram-negative bacilli 3. Currently receiving treatment for the bloodstream infection Exclusion Criteria: 1. Inability to swallow oral MET-2 or placebo capsule 2. Recipient of small bowel transplant 3. Inflammatory bowel disease, short bowel syndrome, diverting/non-diverting ileo/colostomy 4. Use of \>3 days over-the-counter or prescription probiotics (not including food additives) within 10 days of enrolment 5. Receipt of fecal microbiota transplant (FMT) within 3 months of enrolment 6. Absolute neutrophil count \<0.5x109/L 7. Death expected within 72 hours of enrolment 8. Planned continuation of non-prophylaxis antimicrobial therapy active against the bloodstream isolate for \>42 days 9. Known pregnancy, planning to become pregnant during the study period, or breastfeeding 10. Any other reason in view of the site investigator or treating team

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis gram-negative bacterial infections Infections infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antibiotic resistant infection Gram-negative bacteremia Microbial colonization

Contacts and locations

Locations

  • Sinai Health

    Toronto, Ontario, M6G 1X5, Canada

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y 4E9, Canada

  • University Health Network

    Toronto, Ontario, M5G 1L7, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.