Intest Res.  2017 Jan;15(1):68-74. 10.5217/ir.2017.15.1.68.

Single fecal microbiota transplantation failed to change intestinal microbiota and had limited effectiveness against ulcerative colitis in Japanese patients

  • 1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
  • 2Department of Immunology, Keio University School of Medicine, Tokyo, Japan.
  • 3Laboratory of Metagenomics, Graduate School of Frontier Sciences, The University of Tokyo, Chiba, Japan.
  • 4Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan.


Recent developments in analytical techniques including next-generation sequencing have clarified the correlation between intestinal microbiota and inflammatory bowel disease. Fecal microbiota transplantation (FMT) for patients with ulcerative colitis (UC) is proposed as a potential approach to resolving their dysbiosis; however, its safety and efficacy have not been confirmed. This single-arm, open-label, non-randomized study aimed to evaluate the safety and efficacy of FMT for Japanese patients with UC as the first registered clinical trial in Japan.
We enrolled 10 patients with active UC despite medical therapy. The donors were the patients' relatives and were carefully screened for infectious diseases. Fecal material was administered via colonoscopy, and the primary endpoint was the presence or absence of serious adverse events related to FMT. The secondary endpoint was a change in partial Mayo score at 12 weeks post-FMT. Scores ≤2 were considered a clinical response. Fecal samples were collected to follow changes in gut microbiota, while extracted complementary DNA were analyzed by a next-generation sequencer. We obtained written informed consent from all patients and donors. This study was approved by our Institutional Review Board and is registered in the University hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN 000012814).
Five patients with moderate disease and five with severe disease were enrolled. No severe adverse effects were observed. One patient achieved clinical response; however, none of the patients' microbiota diversity recovered to the donor levels.
The use of single FMT for UC was safe; however, we failed to show its clinical efficacy and potential to change the intestinal microbiota.


Colitis, ulcerative; Fecal microbiota transplantation; Dysbiosis

MeSH Terms

Asian Continental Ancestry Group*
Colitis, Ulcerative*
Communicable Diseases
DNA, Complementary
Ethics Committees, Research
Fecal Microbiota Transplantation*
Gastrointestinal Microbiome*
Inflammatory Bowel Diseases
Information Services
Informed Consent
Tissue Donors
Treatment Outcome
DNA, Complementary
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