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Precision Modulation of Gut Microbiome Enteropathogen Colonization in Critical Illness
Sponsor: University of Calgary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2027-01
Completion Date
2029-01
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
Synbiotic
Synbiotic medical nutrition product consisting of probiotic and prebiotic combination
Standard of Care (SOC)
Standard of care without synbiotic treatment.
Locations (1)
Foothills Medical Centre
Calgary, Alberta, Canada