NCT04885946

Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Christian Hvas · Academic / Other
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

Clostridioides difficile (CD) infection (CDI) is a global health threat with an urgent need for new treatment strategies. Faecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (CDI), and is currently recommended for multiple (three or more), recurrent CDI infections. The role of FMT earlier in the treatment hierarchy of CDI remains to be determined. In this randomized, double-blinded, placebo-controlled clinical trial, we compare FMT with placebo following standard antibiotic treatment for first or second Clostridioides difficile infection.

Detailed description

This is a parallel arm placebo-controlled clinical trial. We aim to include 84 adult patients with their first or second episode of Clostridioides difficile (formerly Clostridium difficile) infection. All patients receive vancomycin standard therapy. Patients are randomised in a 1:1 ratio to two treatments with capsules that contain either FMT+FMT or placebo+placebo. The primary outcome is absence of C difficile-associated disease 8 weeks after randomisation. Patients who have fulminant disease where it is deemed unethical to give placebo are offered open-label FMT. The primary outcome in patients with fulminant C difficile infection is 8 weeks mortality.

Conditions

• Clostridium Difficile Infection
• Clostridioides Difficile Infection

Interventions

Type	Name	Description
OTHER	Fecal microbiota transplantion (FMT)	Single donor, fecal microbiota transplantion (FMT) from healthy human donors.
OTHER	Placebo	Food coloring, water, glycerol

Timeline

• Start date: 2021-06-02
• Primary completion: 2022-03-31
• Completion: 2024-12-31
• First posted: 2021-05-13
• Last updated: 2022-06-09

Locations

1 site across 1 country: Denmark