title: Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis.
abstract: BACKGROUND
  The strategy of using fecal microbiota transplantation (FMT) for refractory ulcerative colitis (UC) remains unclear if single FMT failed to induce remission. This study aimed to evaluate the efficacy and safety of a designed step-up FMT strategy for the steroid-dependent UC.
  
  
  METHODS
  Fifteen patients with steroid-dependent UC were enrolled, and treated with step-up FMT strategy. Follow-up clinical data was collected for a minimum of 3 months. Fecal microbiota composition before and post FMT of patients and related donors were analyzed by 16S rRNA sequencing.
  
  
  RESULTS
  Eight of fourteen (57.1 %) patients achieved clinical improvement and were able to discontinue steroids following step-up FMT. One patient was lost to follow-up. Among the 8 patients who responded, five (35.7 %) received one FMT therapy, one (7.1 %) received two FMTs, and two (14.2 %) received two FMTs plus a scheduled course of steroids. Four (28.6 %) of the 8 patients who responded maintained long-term remission during follow-up (3-18 months). Six patients (42.9 %) failed to meet the criteria of clinical improvement and maintained steroid dependence, though three experienced transient or partial improvement. Microbiota analysis showed that FMT altered the composition greatly, and a microbiota composition highly similar to that of the donor emerged in the patients with successful treatment. No severe adverse events occurred during treatment and follow-up.
  
  
  CONCLUSIONS
  Step-up FMT strategy shows promise as a therapeutic strategy for patients with steroid-dependent UC, likely due to the successful restructuring of gut microbial composition.
  
  
  BACKGROUND
  ClinicalTrials.gov, Number NCT01790061.
authors.affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. cuibota@163.com.
authors.forename: Bota
authors.initials: B
authors.lastname: Cui
authors.affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. puddyli@hotmail.com.
authors.forename: Pan
authors.initials: P
authors.lastname: Li
authors.affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. Ljxu_njmu@163.com.
authors.forename: Lijuan
authors.initials: L
authors.lastname: Xu
authors.affiliation: Collega of Precision Instrument and Opto-electronics Engineering, Tianjin University, 92 Weijin Road, 300072, Tianjin, China. sea7man@sina.com.
authors.forename: Youquan
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: Biomedical Engineering Department, School of Electronics and Information Engineering, Tianjin Polytechnic University, 399 Binshui West Street, 300378, Tianjin, China. huiquan85@gmail.com.
authors.forename: Huiquan
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authors.lastname: Wang
authors.affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. zhaoyouquan@tju.edu.cn.
authors.forename: Zhaoyuan
authors.initials: Z
authors.lastname: Peng
authors.affiliation: Clinical Nutrition, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. maiexu@126.com.
authors.forename: Hai'e
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authors.lastname: Xu
authors.affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. 812862173@qq.com.
authors.forename: Jie
authors.initials: J
authors.lastname: Xiang
authors.affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. hezhi0312@163.com.
authors.forename: Zhi
authors.initials: Z
authors.lastname: He
authors.affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. 386962565@qq.com.
authors.forename: Ting
authors.initials: T
authors.lastname: Zhang
authors.affiliation: State Key Laboratory of Cancer Biology and Xijing Hospital of Digestive Diseases, The Fourth Military Medical University, 710032, Xi'an, China. yongznie@fmmu.edu.cn.
authors.forename: Yongzhan
authors.initials: Y
authors.lastname: Nie
authors.affiliation: State Key Laboratory of Cancer Biology and Xijing Hospital of Digestive Diseases, The Fourth Military Medical University, 710032, Xi'an, China. kaicwu@fmmu.edu.cn.
authors.forename: Kaichun
authors.initials: K
authors.lastname: Wu
authors.affiliation: State Key Laboratory of Cancer Biology and Xijing Hospital of Digestive Diseases, The Fourth Military Medical University, 710032, Xi'an, China. fandaim@fmmu.edu.cn.
authors.forename: Daiming
authors.initials: D
authors.lastname: Fan
authors.affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. jgz@njmu.edu.cn.
authors.forename: Guozhong
authors.initials: G
authors.lastname: Ji
authors.affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. fzhang@njmu.edu.cn.
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mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D002648:Child; D003093:Colitis, Ulcerative / Q000188:drug therapy / Q000628:therapy*; D000069467:Fecal Microbiota Transplantation; D005243:Feces / Q000382:microbiology*; D005260:Female; D006801:Humans; D008297:Male; D064307:Microbiota; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D013048:Specimen Handling; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones