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Can a Probiotic-Prebiotic blend stop deadly gut infections in ICU patients?

NCT ID NCT07813507

Prevention Sponsor: University of Calgary 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Critically ill patients on breathing machines often develop dangerous gut bacteria that can lead to hospital-acquired infections. Researchers are testing a synbiotic medical food, a mix of probiotics and prebiotics, to see if it safely reduces these harmful bacteria. The trial enrolls 64 adults in intensive care and compares the synbiotic plus standard care against standard care alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a synbiotic medical food combining probiotics and prebiotics
What this could lead to
If it works, this could offer a way to reduce harmful gut bacteria in critically ill patients and lower their risk of hospital-acquired infections.
What could go wrong
This is an early-stage trial in a small number of very sick patients, so safety and effectiveness are not yet established. The synbiotic may not reduce pathogens or infections, and feeding it to critically ill patients carries unknown risks.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2029

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: * Adult (\>18 years old) admitted to FMC ICU within 48h of admission * Mechanically ventilated via endotracheal tube * Expected duration of mechanical ventilation \>72 hours from time of screening (as determined by attending ICU physician) Exclusion Criteria: * Goals of care designation that limits the use of life-sustaining interventions * Life expectancy \<72 hours (in the opinion of the attending ICU physician) * Unable to receive enteral administration of medications * Presence of ileus, discontinuous GI tract (including ileostomy), total or partial colectomy, bariatric surgery, inflammatory bowel disease, active graft-versus-host disease, cirrhosis with Child-Pugh Class C, or short bowel syndrome * Acute immunosuppression including recent (within 30 days) cytotoxic chemotherapy; chronic systemic steroids (≥20 mg prednisone equivalent/day for \>3 weeks); uncontrolled HIV infection (with CD4 count \<400/μl); neutropenia (absolute neutrophil count \<500/μL) * Pregnancy or breastfeeding * Concurrently taking pre-, pro-, synbiotic, or live biotherapeutic product, or other fermented food product and unwilling to discontinue these for the duration of the study * Concurrently enrolled in another clinical trial of pre-, pro-, synbiotic, or live biotherapeutic product, antimicrobial, or immune modulator therapy * History of lactose allergy (lactose intolerance not exclusionary) * Unsuitable for inclusion in study in the opinion of the attending physician or investigator

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Conditions

The condition(s) this trial relates to.

Critical Illness nosocomial infection

As listed by the trial registrant

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

Critical illness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Foothills Medical Centre

    Calgary, Alberta, T2N 4N1, Canada

More trials for these conditions

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