Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection (EarlyFMT)

Christian Hvas

Status: Active, not recruiting

Conditions: Clostridioides Difficile Infection; Clostridium Difficile Infection

Treatments: Other: Placebo; Other: Fecal microbiota transplantion (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04885946

1-10-72-254-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

42 participants in 3 patient groups, including a placebo group

Vancomycin 125 x 4 for 10 days + 2 Fecal Microbota Transplantation

Experimental group

Description:

Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, FMT.

Treatment:

Other: Fecal microbiota transplantion (FMT)

Vancomycin 125 x 4 for 10 days + 2 Placebo

Placebo Comparator group

Description:

Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, placebo.

Treatment:

Other: Placebo

Open-label for screened, but not randomized patients with fulminant CDI

Other group

Description:

This arm exists for patients with fulminant CDI and for randomization to placebo may be considered unethical.

Treatment:

Other: Fecal microbiota transplantion (FMT)