Critical IllnessPhase 1/2MicroModNCT07813507
Precision Modulation of Gut Microbiome Enteropathogen Colonization in Critical Illness
A Phase 1/2 study testing Synbiotic in people with Critical Illness, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Synbiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2027to Jan 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Foothills Medical Centre
Calgary, Alberta, T2N 4N1
Braedon McDonald, MD, PhD, FRCPC, 1-403-220-6885, bamcdona@ucalgary.ca
Braedon McDonald, MD, PhD, FRCPC
About this study
Official title: 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
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.
Read the detailed description
Enteropathogen colonization of the gut microbiome in critically ill patients is associated with adverse outcomes. Observational studies have consistently reported that gut colonization with enteropathogens including Enterobacterales (e.g. Klebsiella spp., E. coli, Enterobacter spp., and others) and Enterococcus spp. (e.g. E. faecium) is associated with increased risks of hospital-acquired infections, death, organ dysfunction severity, prolongation of life support, and hospitalization. Mechanistically, gut enteropathogen colonization has been shown to contribute to adverse outcomes like hospital-acquired infections (HAI) through the gut's ability to serve as both a reservoir of HAI pathogens, as well as through pathological microbiome-immune interactions that suppress immune defences against HAI. Consequently, therapeutic strategies to reduce gut enteropathogen colonization have been identified as potentially impactful interventions to reduce hospital-acquired infections and adverse outcomes in patients with critical illness.
Prior clinical trials have employed diverse strategies to modulate the gut microbiome with the objective of reducing adverse outcomes, including large randomized controlled trials of probiotics, or opposing strategies such as digestive decontamination. However, outcomes have been heterogeneous owing to a number of crucial methodological limitations of both the interventions as well as study designs. First, despite proposed mechanisms involving microbiome modulation, none of the important trials have actually analyzed the microbiome to confirm whether their intervention favourably modified the microbiome (i.e. lack of confirmation of biological plausibility). Next, investigations of probiotics have suffered from a lack of rationalized designed for their intended mechanism. For example, the large RCT of probiotics in critically ill patients utilized Lactobacillus rhamnosus GG, yet the choice of this particular probiotic was not based on any prior mechanistic data demonstrating that this species could engraft in the ICU microbiome, nor whether it has the potential to displace enteropathogens from the gut. In fact, very few probiotic trials have ever even determined whether the probiotic strain could engraft into the ICU gut microbiome, nor have any trials determined whether interventions successfully decolonized enteropathogens.
To address these limitations, we will conduct a randomized controlled trial to assess both the safety and biological efficacy (microbiome engraftment and enteropathogen decolonization) of the synbiotic medical nutrition product in critically ill patients. In this phase 1b randomized controlled trial, 64 critically ill patients requiring mechanical ventilation will be randomly assigned to a 21-day course of enteral synbiotic or control (open label). Primary outcome will be safety and biological efficacy of synbiotic engraftment in the gut, with secondary outcome of gut enteropathogen colonization.
- Conditions
- Critical Illness
- Being tested
- Synbiotic, Standard of Care (SOC)
- Keywords
- synbiotic, microbiome, enteropathogens, critical illness, nosocomial infections
- Medical subject headings
- Critical Illness, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
Synbiotic medical nutrition product consisting of probiotic and prebiotic combination
Standard of Care (SOC)Other
Standard of care without synbiotic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic treatment | Experimental | Not described Receives: Dietary Supplement: Synbiotic |
| Control | Sham comparator | Standard of care Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Product-related adverse event rates
Product-related adverse event rates
Measured: Enrolment to day 90
Biological efficacy
Magnitude of gut microbiome engraftment by synbiotic
Measured: Enrolment to day 90
Secondary outcomes (1)
Gut enteropathogen colonization
Abundance of enteropathogens in the gut (fecal) microbiome
Measured: Enrolment to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Snyder Institute for Chronic Diseases, KeepBio Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813507
- Sponsor's protocol ID
- REB26-0527
- Acronym
- MicroMod
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Metagenomic gut microbiome sequencing data will be made publicly available at the time of publication of study results.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07813507
- Acronym / sponsor ID
- MicroMod / REB26-0527
- Conditions
- Critical Illness
- Keywords
- synbiotic, microbiome, enteropathogens, critical illness, nosocomial infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Snyder Institute for Chronic Diseases, KeepBio Inc.
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Enteropathogen colonization of the gut microbiome in critically ill patients is associated with adverse outcomes. Observational studies have consistently reported that gut colonization with enteropathogens including Enterobacterales (e.g. Klebsiella spp., E. coli, Enterobacter spp., and others) and Enterococcus spp. (e.g. E. faecium) is associated with increased risks of hospital-acquired infections, death, organ dysfunction severity, prolongation of life support, and hospitalization. Mechanistically, gut enteropathogen colonization has been shown to contribute to adverse outcomes like hospital-acquired infections (HAI) through the gut's ability to serve as both a reservoir of HAI pathogens, as well as through pathological microbiome-immune interactions that suppress immune defences against HAI. Consequently, therapeutic strategies to reduce gut enteropathogen colonization have been identified as potentially impactful interventions to reduce hospital-acquired infections and adverse outcomes in patients with critical illness.
Prior clinical trials have employed diverse strategies to modulate the gut microbiome with the objective of reducing adverse outcomes, including large randomized controlled trials of probiotics, or opposing strategies such as digestive decontamination. However, outcomes have been heterogeneous owing to a number of crucial methodological limitations of both the interventions as well as study designs. First, despite proposed mechanisms involving microbiome modulation, none of the important trials have actually analyzed the microbiome to confirm whether their intervention favourably modified the microbiome (i.e. lack of confirmation of biological plausibility). Next, investigations of probiotics have suffered from a lack of rationalized designed for their intended mechanism. For example, the large RCT of probiotics in critically ill patients utilized Lactobacillus rhamnosus GG, yet the choice of this particular probiotic was not based on any prior mechanistic data demonstrating that this species could engraft in the ICU microbiome, nor whether it has the potential to displace enteropathogens from the gut. In fact, very few probiotic trials have ever even determined whether the probiotic strain could engraft into the ICU gut microbiome, nor have any trials determined whether interventions successfully decolonized enteropathogens.
To address these limitations, we will conduct a randomized controlled trial to assess both the safety and biological efficacy (microbiome engraftment and enteropathogen decolonization) of the synbiotic medical nutrition product in critically ill patients. In this phase 1b randomized controlled trial, 64 critically ill patients requiring mechanical ventilation will be randomly assigned to a 21-day course of enteral synbiotic or control (open label). Primary outcome will be safety and biological efficacy of synbiotic engraftment in the gut, with secondary outcome of gut enteropathogen colonization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic treatment | Experimental | Dietary Supplement: Synbiotic |
| Control | Sham comparator | Other: Standard of Care (SOC)Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SynbioticSynbiotic medical nutrition product consisting of probiotic and prebiotic combination | Dietary supplement | Synbiotic treatment |
| Standard of Care (SOC)Standard of care without synbiotic treatment. | Other | Control |
Primary outcome
Safety - Product-related adverse event rates
Time frame: Enrolment to day 90
Product-related adverse event rates
Biological efficacy
Time frame: Enrolment to day 90
Magnitude of gut microbiome engraftment by synbiotic
1 secondary outcome
Gut enteropathogen colonization
Time frame: Enrolment to day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Metagenomic gut microbiome sequencing data will be made publicly available at the time of publication of study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Synbiotic in people with Critical Illness, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Braedon McDonald, MD, PhD, FRCPC (1-403-220-6885, bamcdona@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Product-related adverse event rates (time frame: Enrolment to day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.