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RCTs are necessary to prove the efficacy of FMT and to determine the optimal route of administration among other variables and safety in immunosuppressed patients needs to be established. An RCT of donor feces administered by duodenal infusion with gut lavage showed significant efficacy compared to vancomycin or avatrade company address with gut lavage without donor feces (104). The study was terminated early because it avatrade company address deemed unethical to continue as the cure rate was 81 compared to 23 with vancomycin alone and 31 with vancomycin and gut lavage.
An NIH-funded blinded RCT is underway, using FMT via colonoscopy with donor or recipient stool for transplant (Colleen Kelly, Lawrence Brandt, personal communication).