A Phase 2 interventional study of LFMT and LSFF in Enterocolitis and Recurrent Clostridium Difficile Infection, sponsored by Dina Kao. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by Dina Kao · Phase 2, Interventional, and Treatment
Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with fecal slurry.
Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of recurrent Clostridium difficile infection (RCDI).
This prospective double blind randomized pilot study will enroll 40 subjects with recurrent Clostridium difficile infection in a 1:1 ratio to receive either LSFF or LFMT by capsules.
Subjects will receive 15 capsules at week 0 and be assessed at Weeks 1, 4, 12 and 24. If treatment fails, subjects will be given open label LFMT from the same donor. If treatment fails again, another FMT will be offered and the form and route of FMT delivery will be at the discretion of the treating physician.
Exclusion Criteria:
Lyophilized fecal microbiota transplant capsules
Biological: LFMT
Lyophilized sterile fecal filtrate capsules
Biological: LSFF
Lyophilized fecal microbiota transplant
Lyophilized sterile fecal filtrate
Resolution of RCDI
Proportion of subjects without RCDI
Time frame: 8 weeks
Resolution of RCDI
Proportion of subjects with sustained cure
Time frame: 24 weeks
Serious Adverse Events
Mortality directly attributable to CDI or treatment
Time frame: 8 weeks
Serious Adverse Events
Infection directly attributable to treatment
Time frame: 8 weeks
Minor Adverse Events
nausea
Time frame: 1 week
Minor Adverse Events
vomiting
Time frame: 1 week
Minor Adverse Events
abdominal pain
Time frame: 1 week
Difficulty in swallowing capsules
Reported by subjects as ranging between none, moderate or severe
Time frame: 1 week
Plan to share: No
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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