Clostridioides Difficile Infection Recurrence, FMT
Conditions
Keywords
Clostridioides Difficile infection, FMT, Capsule
Brief summary
Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.
Detailed description
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.
Interventions
BIOLOGICALHealthy donor stool
Healthy donor stool given by capsules produced by the same method as in Copenhagen University Hospital
BIOLOGICALplacebo capsule
Copenhagen University Hvidrovre Hospital method for capsule production
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Remission of symptoms during antibiotic course (metronidazole, vancomycin or fidaxomicin) * No other antibiotic courses * Able to sign the consent form or accept it electronically via Suomi.fi identification * definition of recurrent CDI: CDI-compatible symptoms and a positive stool test Clostridioides difficile nucleic acid test within 12 weeks of the previous infection
Exclusion criteria
* Pregnancy * Continuous need for antibiotic treatment * Previous anaphylactic reactions to any food * Gastroparesis * Life-threatening fulminant CDI * Life expectancy less than 1 year * Inability to sign a consent form for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 evaluate the number of patietns who get rCDI within 12 weeks after FMT (Placebo or active 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with side effects after FMT capsules. | One, four and twelve weeks after FMT (placebo or active FMT). | 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. |
Countries
Finland
Contacts
CONTACTPerttu Arkkila, Professor
CONTACTSuvi Niku, PhD, MD
PRINCIPAL_INVESTIGATORPerttu Arkkila, Professor
Helsinki University Central Hospital
Outcome results
None listed