World Congress at ACG2017

Simultaneous Plenary Session 4B: Esophagus / Colon

66 - Low Resolution rates in Open-Label and Randomized Controlled Trials of Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection: A Systematic Review and Meta-Analysis

Wednesday, October 18
9:00 AM - 9:10 AM
Location: Valencia Ballroom D (Level 4)



Category: Colon       

Raseen Tariq, MBBS, Darrell S. Pardi, MD, MS, Mark Bartlett, MD, Sahil Khanna, MBBS, MS
Mayo Clinic, Rochester, MN
Introduction: Fecal Microbiota Transplantation (FMT) has been shown to be highly effective to treat recurrent Clostridium difficile infection (CDI) in observational studies (cure rates >90%) but efficacy in controlled clinical trials has been lower. We performed a systematic review and meta-analysis to assess the efficacy of FMT for recurrent CDI in open-label registered prospective clinical trials and in randomized controlled trials (RCTs).

Methods: A systematic search of Embase, Web of Science and Scopus was performed up to March 2017 to identify studies of interest. Clinical trials of FMT for recurrent/refractory CDI with clinical resolution as the primary outcome were included. We calculated both unweighted and weighted pooled resolution rates (UPR and WPR) with 95% confidence intervals (CI) for overall and subgroup analyses.

Results: Thirteen studies (6 RCTs and 7 open-label trials) with a total of 610 patients treated with FMT were included. Of the patients treated with FMT, 439 of 610 patients experienced symptom resolution (UPR 71.9%; WPR 76.1%, 95% CI, 66.4-85.7). There was significant heterogeneity among studies with an I2 of 91.4%. Analysis of trials with a control arm (non-FMT) revealed CDI resolution in 139 of 216 patients (UPR 64.3%; WPR 67.7%, 95%CI 54.2-81.3). Among the 7 open-label clinical trials, CDI resolution was seen in 300 of 394 patients after initial FMT (UPR 76.1%; WPR 82.7%, 95%CI 71.1-94.3). Comparison of resolution rates between RCTs and open-label trials revealed a lower cure rate in RCTs compared to open-label trials (WPR 67.7% vs 82.7%, p < 0.0001). There were no serious adverse events reported.

Subgroup analysis based on FMT delivery modality revealed a lower resolution rate with enema compared to colonoscopy (WPR 66.3% vs 87.4%, p < 0.0001) but no difference between colonoscopy and oral route (WPR 87.4% vs 81.4%, p=0.17). Comparing FMT for recurrent vs refractory CDI revealed lower resolution rates among studies that used FMT for both recurrent and refractory CDI compared to recurrent CDI only (WPR 63.9% vs 79%, p=0.0001).

Discussion: FMT in a controlled setting leads to lower resolution rates compared to observational studies, likely due to strict definitions of clinical resolution and CDI recurrences. Further studies are needed to explore factors predicting these differences between case-series and controlled settings.

Supported by Industry Grant: No


Citation: . LOW RESOLUTION RATES IN OPEN-LABEL AND RANDOMIZED CONTROLLED TRIALS OF FECAL MICROBIOTA TRANSPLANTATION FOR RECURRENT CLOSTRIDIUM DIFFICILE INFECTION: A SYSTEMATIC REVIEW AND META-ANALYSIS. Program No. 66. World Congress of Gastroenterology at ACG2017 Meeting Abstracts. Orlando, FL: American College of Gastroenterology.

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66 - Low Resolution rates in Open-Label and Randomized Controlled Trials of Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection: A Systematic Review and Meta-Analysis



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