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NOT YET RECRUITING
NCT07813507
PHASE1/PHASE2

Precision Modulation of Gut Microbiome Enteropathogen Colonization in Critical Illness

Sponsor: University of Calgary

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Synbiotic

Synbiotic medical nutrition product consisting of probiotic and prebiotic combination

OTHER

Standard of Care (SOC)

Standard of care without synbiotic treatment.

Locations (1)

Foothills Medical Centre

Calgary, Alberta, Canada