Methods |
Randomized, controlled, pilot study |
Participants |
Inclusion criteria
Age >18 years
Diagnosis of ≥ 3 episodes of rCDI, each episode defined by presence of diarrhea (≥ 3 unformed stools/24 hours), positive for C difficile toxin, episodes occurring within 2 months of each other after finishing anti‐CDI therapy, and recurring diarrhea after symptom resolution following ≥ 10 days of anti‐CDI therapy
CDI infection under symptomatic control with < 3 loose/unformed stools/24 hours for ≥ 2 consecutive days before treatment
Ability to provide informed consent
Exclusion criteria
Fulminant CDI
Chronic diarrheal illness
Taking or planning to take investigational drug within 3 months of enrollment
Dysphagia
Ileus or bowel obstruction
Pregnancy
Active infection requiring antibiotic therapy
Life expectancy < 6 months
|
Interventions |
Intervention Single dose of 15 capsules of lyophilized donor stool Comparison Single dose of 15 capsules of lyophilized sterile fecal filtrate |
Outcomes |
Primary outcome
Proportion of participants in each group with no CDI recurrence at week 8
Secondary outcomes
Mortality rate at week 8
Infections directly attributable to CDI or treatment at week 8
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Notes |
While this study meets criteria and has been completed there was not enough information for us to complete the risk of bias assessment and include the data in the analysis. |