FMT Capsules for rCDI
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelsinki University Central Hospital
About this trial
Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least twice recurrent CDI*
Patient has had CDI-related diarrhea during infections (3 or more Bristol Stool Form Scale type 6-7 stools)
Other causes of diarrhea have been excluded based on clinical data
Age over 18 years
Disqualifiers
Pregnancy
Continuous need for antibiotic treatment
Previous anaphylactic reactions to any food
Gastroparesis
Trial design
Design model
Parallel
Treatments tested in this trial
Healthy donor stool
Biological/VaccineHealthy donor stool given by capsules produced by the same method as in Copenhagen University Hospital
placebo capsule
Biological/VaccineCopenhagen University Hvidrovre Hospital method for capsule production
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Patients receiving active treatmentExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).Secondary outcomes
1
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov