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Phase 1b randomized controlled trial evaluating medical food synbiotic KB-101+KB-102 for safety and dietary management of enteropathogen colonization of the gut microbiome of critically ill patients

NCT ID NCT07813507

NEW 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026

Summary

Patients requiring life support therapies in intensive care units are at very high risk of hospital-acquired infections. An important source of these infections is the accumulation of pathogenic bacteria in the microbiome of their gut. We hypothesize that treatment with an enteral synbiotic (combination of probiotic and prebiotic), which has been specifically designed to combat pathogen colonization in the gastrointestinal tract, will be safe and effective to reduce pathogen levels in the gut, and potentially reduce infections. We are conducting a phase 1b randomized, open-label, controlled trial to assess safety biological efficacy of enteral synbiotic therapy to reduce gastrointestinal enteropathogen colonization in adult critically ill patients.

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

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