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.
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)
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
Parallel
Synbiotic
Dietary supplementSynbiotic medical nutrition product consisting of probiotic and prebiotic combination
Standard of Care (SOC)
Other interventionStandard of care without synbiotic treatment.
Safety - Product-related adverse event rates
Product-related adverse event rates
Biological efficacy
Magnitude of gut microbiome engraftment by synbiotic
Gut enteropathogen colonization
Abundance of enteropathogens in the gut (fecal) microbiome
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University of Calgary
Lead sponsor
Snyder Institute for Chronic Diseases
Collaborator
KeepBio Inc.
Collaborator
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