Double blind, placebo-controlled, parallel, multicentric trial to investigat whether Nagasin® can support the colonization resistance against C.difficile.
The aim of this randomized, controlled, double-blind, parallel, multicentric trial is to investigate wether the synbiotic food supplement Nagasin® can support the colonization resistance of the gut microbiota after disturbance by antimicrobial treatment. The main question is whether Nagasin® can prevent any increase in abundance of C.difficile within the first four weeks after antimicrobial treatment for a C. difficile infection. Participants will receive Nagasin® or the comparator as a food supplement during the first four weeks after antimicrobial treatment for a C. difficile episode.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
49
Lactobacillus, Lactococcus and Bifidobacteria strains with antimicrobial effect against C. difficile
maltodextrin (placebo comparator)
Kantonsspital Baselland
Liestal, Basel-Landschaft, Switzerland
Inselspital Bern
Bern, Canton of Bern, Switzerland
Luzerner Kantonsspital
Lucerne, Canton of Lucerne, Switzerland
Kantonsspital Winterthur
Winterthur, Canton of Zurich, Switzerland
C. difficile relative abundance
any change of C. difficile relative abundance during the first four weeks after antimicrobial treatment for CDI.
Time frame: at 1, 2 and 4 weeks after completion of antimicrobial treatment for CDI
Gut microbiota
Gut microbiota diversity and taxonomic composition
Time frame: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
Abundance of antibiotic diarrhea associated pathogens
Abundance of other pathogens that are involved in antibiotic associated diarrhea e.g. S. aureus and K. oxytoca
Time frame: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
C. difficile toxins
Presence and amount of C. difficile toxins
Time frame: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
Toxin forming C. difficile strains
Presence of toxin forming C. difficile strains
Time frame: at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI
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Stadtspital Zürich
Zurich, Canton of Zurich, Switzerland
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland