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

Shinta Mizuno, Kosaku Nanki, Katsuyoshi Matsuoka, Keiichiro Saigusa, Keiko Ono, Mari Arai, Shinya Sugimoto, Hiroki Kiyohara, Moeko Nakashima, Kozue Takeshita, Makoto Naganuma, Wataru Suda, Masahira Hattori, Takanori Kanai

    Research output: Contribution to journalArticle

    10 Citations (Scopus)

    Abstract

    Background/Aims: 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. Methods: 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). Results: 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. Conclusions: The use of single FMT for UC was safe; however, we failed to show its clinical efficacy and potential to change the intestinal microbiota.

    Original languageEnglish
    Pages (from-to)68-74
    Number of pages7
    JournalIntestinal Research
    Volume15
    Issue number1
    DOIs
    Publication statusPublished - 2017

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    Ulcerative Colitis
    Information Services
    Tissue Donors
    Dysbiosis
    Clinical Trials
    Safety
    Gastrointestinal Microbiome
    Fecal Microbiota Transplantation
    Research Ethics Committees
    Microbiota
    Colonoscopy
    Informed Consent
    Inflammatory Bowel Diseases
    Communicable Diseases
    Registries
    Japan
    Complementary DNA

    Keywords

    • Colitis
    • Dysbiosis
    • Fecal microbiota transplantation
    • Ulcerative

    ASJC Scopus subject areas

    • Gastroenterology

    Cite this

    Single fecal microbiota transplantation failed to change intestinal microbiota and had limited effectiveness against ulcerative colitis in Japanese patients. / Mizuno, Shinta; Nanki, Kosaku; Matsuoka, Katsuyoshi; Saigusa, Keiichiro; Ono, Keiko; Arai, Mari; Sugimoto, Shinya; Kiyohara, Hiroki; Nakashima, Moeko; Takeshita, Kozue; Naganuma, Makoto; Suda, Wataru; Hattori, Masahira; Kanai, Takanori.

    In: Intestinal Research, Vol. 15, No. 1, 2017, p. 68-74.

    Research output: Contribution to journalArticle

    Mizuno, S, Nanki, K, Matsuoka, K, Saigusa, K, Ono, K, Arai, M, Sugimoto, S, Kiyohara, H, Nakashima, M, Takeshita, K, Naganuma, M, Suda, W, Hattori, M & Kanai, T 2017, 'Single fecal microbiota transplantation failed to change intestinal microbiota and had limited effectiveness against ulcerative colitis in Japanese patients' Intestinal Research, vol. 15, no. 1, pp. 68-74. https://doi.org/10.5217/ir.2017.15.1.68
    Mizuno, Shinta ; Nanki, Kosaku ; Matsuoka, Katsuyoshi ; Saigusa, Keiichiro ; Ono, Keiko ; Arai, Mari ; Sugimoto, Shinya ; Kiyohara, Hiroki ; Nakashima, Moeko ; Takeshita, Kozue ; Naganuma, Makoto ; Suda, Wataru ; Hattori, Masahira ; Kanai, Takanori. / Single fecal microbiota transplantation failed to change intestinal microbiota and had limited effectiveness against ulcerative colitis in Japanese patients. In: Intestinal Research. 2017 ; Vol. 15, No. 1. pp. 68-74.
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    abstract = "Background/Aims: 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. Methods: 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). Results: 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. Conclusions: The use of single FMT for UC was safe; however, we failed to show its clinical efficacy and potential to change the intestinal microbiota.",
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    AU - Mizuno, Shinta

    AU - Nanki, Kosaku

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    AU - Saigusa, Keiichiro

    AU - Ono, Keiko

    AU - Arai, Mari

    AU - Sugimoto, Shinya

    AU - Kiyohara, Hiroki

    AU - Nakashima, Moeko

    AU - Takeshita, Kozue

    AU - Naganuma, Makoto

    AU - Suda, Wataru

    AU - Hattori, Masahira

    AU - Kanai, Takanori

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    N2 - Background/Aims: 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. Methods: 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). Results: 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. Conclusions: The use of single FMT for UC was safe; however, we failed to show its clinical efficacy and potential to change the intestinal microbiota.

    AB - Background/Aims: 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. Methods: 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). Results: 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. Conclusions: The use of single FMT for UC was safe; however, we failed to show its clinical efficacy and potential to change the intestinal microbiota.

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