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

Dubberke 2018.

Methods Randomized, double‐blind, placebo‐controlled, phase 2b study
Participants Inclusion criteria
  1. Aged ≥ 18 years

  2. Medical record documentation of rCDI either: ≥ 2 recurrences after a primary episode and has completed ≥ 2 rounds of standard‐of‐care oral antibiotic therapy or has had ≥ 2 episodes of severe CDI resulting in hospitalization

  3. Documented history that the person's rCDI is controlled while on antibiotics even if the person is not currently on antibiotics

  4. A positive stool test for the presence of C difficile within 60 days prior to enrollment


Exclusion criteria
  1. History of continued C difficile diarrhea while on a course of antibiotics prescribed for CDI treatment

  2. Requires antibiotic therapy for a condition other than rCDI

  3. Previous fecal transplant prior to study enrollment

  4. History of inflammatory bowel disease

  5. History of irritable bowel syndrome

  6. History of chronic diarrhea

  7. History of celiac disease

  8. Colostomy

  9. Planned surgery requiring perioperative antibiotics within 6 months of study enrollment

  10. Life expectancy < 12 months

  11. Compromised immune system

Interventions Intervention
Group A: 2 enemas of RBX2660 (microbiota suspension) administered 7 days apart
Group C: 1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo (a suspension of saline and cryoprotectant) administered 7 days apart
Comparison
Group B: 2 enemas of placebo (a suspension of saline and cryoprotectant) administered 7 days apart
Outcomes Primary outcome
  1. Treatment success of Group A versus Group B assessed at 8 weeks


Secondary outcome
  1. Treatment success between Group C versus Group B assessed at 8 weeks

  2. Treatment success evaluated between Group A versus Group C assessed at 8 weeks

  3. 36‐item Short Form Health Survey (SF‐36) scores obtained at 1, 4, and 8‐week assessment visits during the double‐blind period as compared to baseline assessed at 8 weeks

  4. Time to CDAD recurrence after completion of the assigned study treatment for Group A versus Group B at 8 weeks

  5. Time to CDAD recurrence after completion of the assigned study treatment for Group C versus Group B at 8 weeks

  6. Time to CDAD recurrence after completion of the assigned study treatment for Group A versus Group C at 8 weeks

Notes Based on the proprietary nature and our lack of access to procedures between the collection of donor stool and shipping of the RBX2660 microbiota suspension, it is unclear at the time of this publication whether the RBX2660 'microbiota suspension' technically qualifies as FMT per se. We will contact the study authors to request additional details and this study may qualify for inclusion in future versions of this systematic review and meta‐analysis.