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Clinical Trials in Canada / NCT07813507
Starting soon Phase 1/2

Precision Modulation of Gut Microbiome Enteropathogen Colonization in Critical Illness

NCT07813507 · tracked via the Priya Life Science Canada tracker
Phase
Phase 1/2
Started
2027-01
Last updated
2026-09-10

Condition(s) studied

Critical Illness

Investigational drug(s) / intervention(s)

SynbioticStandard of Care (SOC)

Synbiotic: Synbiotic medical nutrition product consisting of probiotic and prebiotic combination

Standard of Care (SOC): Standard of care without synbiotic treatment.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Foothills Medical Centre Calgary Alberta

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07813507 on ClinicalTrials.gov ↗ ← All trials in Canada