NCT05800704

Support of Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin®

Randomized, Controlled, Double-blind, Parallel, Multicentric Study to Investigate Support of the Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin® After Disturbance by Antimicrobial Treatment

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

Double blind, placebo-controlled, parallel, multicentric trial to investigat whether Nagasin® can support the colonization resistance against C.difficile.

Detailed description

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.

Conditions

• C. Difficile Enteritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nagasin	Lactobacillus, Lactococcus and Bifidobacteria strains with antimicrobial effect against C. difficile
DIETARY_SUPPLEMENT	maltodextrin	maltodextrin (placebo comparator)

Timeline

• Start date: 2023-03-10
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2023-04-06
• Last updated: 2025-03-28

Locations

6 sites across 1 country: Switzerland