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. 2023 Apr 25;2023(4):CD013871. doi: 10.1002/14651858.CD013871.pub2

Kao 2019.

Methods Randomized, controlled, pilot study
Participants Inclusion criteria
  1. Age >18 years

  2. 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

  3. CDI infection under symptomatic control with < 3 loose/unformed stools/24 hours for ≥ 2 consecutive days before treatment

  4. Ability to provide informed consent


Exclusion criteria
  1. Fulminant CDI

  2. Chronic diarrheal illness

  3. Taking or planning to take investigational drug within 3 months of enrollment

  4. Dysphagia

  5. Ileus or bowel obstruction

  6. Pregnancy

  7. Active infection requiring antibiotic therapy

  8. 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
  1. Proportion of participants in each group with no CDI recurrence at week 8


Secondary outcomes
  1. Mortality rate at week 8

  2. Infections directly attributable to CDI or treatment at week 8

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.