Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection

Clostridium Difficile Infection Clinical Trial

— EarlyFMT  

Official title:

Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04885946
• Other study ID #: 1-10-72-254-20
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Clostridioides Difficile Infection
• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections

Intervention

Other:
• Fecal microbiota transplantion (FMT)
Single donor, fecal microbiota transplantion (FMT) from healthy human donors.
• Placebo
Food coloring, water, glycerol

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
Christian Hvas	Innovation Fund Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of CD-associated diarrhea (CDAD) week 8	Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.	8 weeks following treatment
Primary	Mortality week 8	In the open-label arm for patients who cannot be randomized due to ethical reasons, the primary outcome is mortality.	8 weeks following treatment
Secondary	Resolution of CD-associated diarrhea (CDAD) week 1	Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.	1 week following treatment
Secondary	Negative CD toxin-test week 1	Faecal C difficile PCR test	1 week following treatment
Secondary	Negative CD toxin-test week 8	Faecal C difficile PCR test	8 weeks following treatment
Secondary	Mortality week 8	Date of death	8 weeks
Secondary	Colectomy rate week 8	Date of colectomy	8 weeks
Secondary	Health-related quality of life	EDQ5D-5L	8 weeks