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      The Safety of Fecal Microbiota Transplantation for Crohn’s Disease: Findings from A Long-Term Study

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          Abstract

          Introduction

          Fecal microbiota transplantation (FMT) has been used as a potential treatment option for Crohn’s disease (CD). However, there is still lack of safety and efficacy evidence based on large samples of CD undergoing FMT. This study aimed to evaluate the risk factors of adverse event (AE) in the long term and the efficacy of FMT in the short term for patients with CD.

          Methods

          FMT via mid-gut for mild to severe CD in a single center trial (NCT01793831) was performed from October 2012 to December 2016. The possible factors with AE and efficacy after FMT were prospectively recorded.

          Results

          A total of 184 frequencies of FMT were performed for 139 patients who received FMT. During 1 month after FMT, 13.6% of mild AEs occurred, including increased frequency of defecation, fever, abdominal pain, flatulence, hematochezia, vomiturition, bloating and herpes zoster. No AE beyond 1 month was observed. Therefore, a 1 month cut-off could be suggested to define short-term and long-term AEs of FMT. Among the possible risk factors, only fecal microbiota purification methods were closely associated with the occurrence of AEs. The rate of AEs in patients undergoing manual methods for the preparation of fecal microbiota was 21.7%, which was significantly higher than the 8.7% in those experiencing an automatic method. The manual or automatic purification of fecal microbiota had no correlation with the efficacy of FMT.

          Conclusion

          This cohort study based on the largest size of cases demonstrated that improved fecal microbiota preparation reduced the rates of AEs, but did not affect the clinical efficacy in patients with CD.

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          Most cited references23

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          Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial.

          Ulcerative colitis (UC) is difficult to treat, and standard therapy does not always induce remission. Fecal microbiota transplantation (FMT) is an alternative approach that induced remission in small series of patients with active UC. We investigated its safety and efficacy in a placebo-controlled randomized trial.
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            Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial.

            The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis.
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              Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis.

              Several case series have reported the effects of fecal microbiota transplantation (FMT) for ulcerative colitis (UC). We assessed the efficacy and safety of FMT for patients with UC in a double-blind randomized trial. Patients with mild to moderately active UC (n = 50) were assigned to groups that underwent FMT with feces from healthy donors or were given autologous fecal microbiota (control); each transplant was administered via nasoduodenal tube at the start of the study and 3 weeks later. The study was performed at the Academic Medical Center in Amsterdam from June 2011 through May 2014. The composite primary end point was clinical remission (simple clinical colitis activity index scores ≤2) combined with ≥1-point decrease in the Mayo endoscopic score at week 12. Secondary end points were safety and microbiota composition by phylogenetic microarray in fecal samples. Thirty-seven patients completed the primary end point assessment. In the intention-to-treat analysis, 7 of 23 patients who received fecal transplants from healthy donors (30.4%) and 5 of 25 controls (20.0%) achieved the primary end point (P = .51). In the per-protocol analysis, 7 of 17 patients who received fecal transplants from healthy donors (41.2%) and 5 of 20 controls (25.0%) achieved the primary end point (P = .29). Serious adverse events occurred in 4 patients (2 in the FMT group), but these were not considered to be related to the FMT. At 12 weeks, the microbiota of responders in the FMT group was similar to that of their healthy donors; remission was associated with proportions of Clostridium clusters IV and XIVa. In this phase 2 trial, there was no statistically significant difference in clinical and endoscopic remission between patients with UC who received fecal transplants from healthy donors and those who received their own fecal microbiota, which may be due to limited numbers. However, the microbiota of responders had distinct features from that of nonresponders, warranting further study. ClinicalTrials.gov Number: NCT01650038. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                jgz@njmu.edu.cn
                fzhang@njmu.edu.cn
                Journal
                Adv Ther
                Adv Ther
                Advances in Therapy
                Springer Healthcare (Cheshire )
                0741-238X
                1865-8652
                16 October 2018
                16 October 2018
                2018
                : 35
                : 11
                : 1935-1944
                Affiliations
                [1 ]GRID grid.452511.6, Medical Center for Digestive Diseases, , Second Affiliated Hospital of Nanjing Medical University, ; Nanjing, China
                [2 ]ISNI 0000 0000 9255 8984, GRID grid.89957.3a, Department of Gastroenterology, , The Affiliated Huaian No. 1 People’s Hospital of Nanjing Medical University, ; Huai’an, China
                [3 ]ISNI 0000 0000 9255 8984, GRID grid.89957.3a, Key Lab of Holistic Integrative Enterology, , Nanjing Medical University, ; Nanjing, China
                [4 ]National Clinical Research Center for Digestive Diseases, Xi’an, China
                Author information
                http://orcid.org/0000-0003-4157-1144
                Article
                800
                10.1007/s12325-018-0800-3
                6223988
                30328062
                65da9b17-abed-4e31-b284-25b49609ab49
                © The Author(s) 2018
                History
                : 18 August 2018
                Funding
                Funded by: China National Science Foundation
                Award ID: 81670495
                Award ID: 81600417
                Award Recipient :
                Funded by: National Clinical Research Center for Digestive Diseases
                Award ID: 2015BAI13B07
                Funded by: Jiangsu Province Medicine Creation Team and Leading Talents project
                Funded by: Intestine Initiative Foundation
                Categories
                Original Research
                Custom metadata
                © Springer Healthcare Ltd., part of Springer Nature 2018

                adverse event,crohn’s disease,fecal microbiota transplantation,gastroenterology,safety

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