Clinical trial NCT04885946: Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection
Official title: Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clostridium Difficile Infection
Clostridioides Difficile Infection
Keywords: Fecal microbiota tranplantation, FMT, CDI
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Innovation Fund Denmark
First posted: 2021-05-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients are randomized to either vancomycin + 2 FMT or 2 placebo. An open-label arm exists for patients with fulminant CDI.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resolution of CD-associated diarrhea (CDAD) week 8
timeFrame: 8 weeks following treatment
measure: Mortality week 8
timeFrame: 8 weeks following treatment
Secondary outcomes:
measure: Resolution of CD-associated diarrhea (CDAD) week 1
timeFrame: 1 week following treatment
measure: Negative CD toxin-test week 1
timeFrame: 1 week following treatment
measure: Negative CD toxin-test week 8
timeFrame: 8 weeks following treatment
measure: Mortality week 8
timeFrame: 8 weeks
measure: Colectomy rate week 8
timeFrame: 8 weeks
measure: Health-related quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Christian L Hvas, PhD
role: STUDY_CHAIR
References:
citation: Baunwall SMD, Andreasen SE, Hansen MM, Kelsen J, Hoyer KL, Ragard N, Eriksen LL, Stoy S, Rubak T, Damsgaard EMS, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL. Faecal microbiota transplantation for first or second Clostridioides difficile infection (EarlyFMT): a randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Dec;7(12):1083-1091. doi: 10.1016/S2468-1253(22)00276-X. Epub 2022 Sep 22.