Methods |
Randomized, double‐blind, placebo‐controlled, phase 2b study |
Participants |
Inclusion criteria
Aged ≥ 18 years
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
Documented history that the person's rCDI is controlled while on antibiotics even if the person is not currently on antibiotics
A positive stool test for the presence of C difficile within 60 days prior to enrollment
Exclusion criteria
History of continued C difficile diarrhea while on a course of antibiotics prescribed for CDI treatment
Requires antibiotic therapy for a condition other than rCDI
Previous fecal transplant prior to study enrollment
History of inflammatory bowel disease
History of irritable bowel syndrome
History of chronic diarrhea
History of celiac disease
Colostomy
Planned surgery requiring perioperative antibiotics within 6 months of study enrollment
Life expectancy < 12 months
Compromised immune system
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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
Treatment success of Group A versus Group B assessed at 8 weeks
Secondary outcome
Treatment success between Group C versus Group B assessed at 8 weeks
Treatment success evaluated between Group A versus Group C assessed at 8 weeks
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
Time to CDAD recurrence after completion of the assigned study treatment for Group A versus Group B at 8 weeks
Time to CDAD recurrence after completion of the assigned study treatment for Group C versus Group B at 8 weeks
Time to CDAD recurrence after completion of the assigned study treatment for Group A versus Group C at 8 weeks
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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. |