A Dual Center, Randomized Trial Comparing Colonoscopy and Oral Capsule Delivered Fecal Microbiota Transplantation in the Treatment of Recurrent Clostridium difficile Infection: Preliminary Results Presidential Poster

Abstract

Introduction: Fecal microbiota transplantation (FMT) is highly effective in the treatment of recurrent Clostridium difficile infection (RCDI). Delivery of FMT by upper route, including gastroscopy or nasogastric tube, and lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized successfully. However, the ideal route of delivering FMT has not yet been determined. Methods: This prospective, dual center trial randomized patients with RCDI in Edmonton and Calgary, Alberta, to receive FMT by oral capsule or colonoscopy at 1:1 ratio. Inclusion criteria were: 1) age > 18 and 2) at least 3 episodes of CDI. Exclusion criteria were: 1) severe CDI; 2) chronic diarrhea; 3) radiation or chemotherapy; 4) dysphagia; 5) ileus or small bowel obstruction; 6) colostomy or ileostomy; 7) pregnancy or breast feeding; 8) life expectancy < 3 months. Seven universal stool donors provided stool materials. Each stool donation consisted of approximately 100g of raw stool, and was processed to produce 400 cc of fecal slurry for colonoscopy delivery, or to 40-60 capsules for oral ingestion. They were stored at -700C before use. The primary objective was to compare the cure rate of RCDI by FMT delivered by capsules versus colonoscopy. The secondary objectives included: 1) safety of FMT by each delivery modality; 2) patient preference and satisfaction; and 3) cost difference between the two modalities. Results: A total of 29 patients had been randomized to date, with 13 in capsule group and 16 in colonoscopy group. Patient baseline characteristics were shown in table 1. The cure rate was 100% in colonoscopy and 92% in capsule group following one treatment. There were no fevers, infections attributable to FMT, or colonic perforation. One patient had mild nausea and vomiting from sedation following colonoscopy. One patient had nausea and vomiting following capsule ingestion. At screening, only 7% of patients found the idea of FMT by capsules unpleasant, compared to 24% by colonoscopy. However, none of the patients had any concern with regards to the actual group they were assigned to. Costs for FMT production were $190 for capsules/dose and $150/dose for colonoscopy. Conclusion: FMT by either colonoscpy or capsules appeared to be similar in efficacy. No significant adverse events had occurred in any patients in either group. More patients preferred the idea of FMT delivery by capsules compared to colonoscopy. FMT administration by capsules were cheaper than by colonoscopy.Table 1: Patient characteristics