Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection

Not Applicable

Active, not recruiting

• Conditions: Clostridium Difficile Infection; Clostridioides Difficile Infection

• Registration Number: NCT04885946
• Lead Sponsor: Christian Hvas

Brief 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.

Study Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-13
• Study Start: 2021-06-02
• Primary Completion: 2022-03-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-09
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• 1. or 2. CDI (within a year) defined as: > 3 bowel movements of Bristol 6-7 per day and positive stool CD-test.
• Age 18 years or higher.

Exclusion Criteria

• Pregnancy
• Does not speak or understand the Danish language
• Current antibiotic treatment other than vancomycin
• Current treatment with potential interations with vancomycin
• Allergy to vancomycin
• Previous anaphylactic reactions due to food allergies
• Continuous need for proton pump inhibitor
• Documented gastroparesis
• Fulminant CDI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Resolution of CD-associated diarrhea (CDAD) week 8	8 weeks following treatment	Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.
Mortality week 8	8 weeks following treatment	In the open-label arm for patients who cannot be randomized due to ethical reasons, the primary outcome is mortality.

Secondary Outcome Measures

Name	Time	Method
Resolution of CD-associated diarrhea (CDAD) week 1	1 week following treatment	Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.
Mortality week 8	8 weeks	Date of death
Colectomy rate week 8	8 weeks	Date of colectomy
Negative CD toxin-test week 8	8 weeks following treatment	Faecal C difficile PCR test
Negative CD toxin-test week 1	1 week following treatment	Faecal C difficile PCR test
Health-related quality of life	8 weeks	EDQ5D-5L

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark