Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.
The aim of the study is to investigate the efficacy and safety of fecal capsules in the treatment of recurrent Clostridioides difficile infection in a double-blind RCT. The study will also investigate whether stool antigen testing or accurate clinical information on risk factors can identify patients who would benefit most from fecal transplantation. The study will include 76 patients who have had recurrent Clostridioides difficile infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
Healthy donor stool given by capsules produced by the same method as in Copenhagen University Hospital
Copenhagen University Hvidrovre Hospital method for capsule production
Helsinki University Hospital
Helsinki, Uusimaa, Finland
Number of patients with recurrence of Clostridioides difficile infection (rCDI), defined as positive fecal Clostridioides difficile nucleinic acid measurement and diarrhea after Fecal Microbiota transplantation (FMT) within 12 weeks after FMT.
The investigators compare the number of patients with rCDI in different groups (placebo vs active FMT group) evaluated by Clostridioides difficile nucleinic acid measurement.
Time frame: The investigators evaluate the number of patietns who get rCDI within 12 weeks after FMT (Placebo or active FMT).
Number of patients with side effects after FMT capsules.
Number of patients with side effects after FMT capsules. Number of Safety of FMT capsules is recorded by contacting the patient by phone call after 1 week and by answering the questionnaire after 1, 4 and 12 weeks after FMT (placebo or active FMT). Questionnaire includes information about any symptoms or signs possible related to recurrecy of CDI, such as fever (defined the temperature over 38 degrees), and diarrhea (defindes as more tahn three loose stool per day). Rate of side effects will be expressed by percentage of the patients.
Time frame: One, four and twelve weeks after FMT (placebo or active FMT).
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