| Project/Area Number |
16K09328
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Gastroenterology
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| Research Institution | Juntendo University |
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Principal Investigator |
Ishikawa Dai 順天堂大学, 医学部, 准教授 (30622675)
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| Co-Investigator(Kenkyū-buntansha) |
佐々木 崇 順天堂大学, 医学部, 非常勤助教 (50723897)
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| Project Period (FY) |
2016-04-01 – 2019-03-31
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| Project Status |
Completed (Fiscal Year 2018)
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| Budget Amount *help |
¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2018: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2017: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2016: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
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| Keywords | 潰瘍性大腸炎 / 便移植療法 / 抗菌薬併用便移植療法 / バクテロイデス / 腸内細菌療法 / 抗菌剤療法 / 定着メカニズム / 多様性の改善 / Bacteoridetes / 菌種レベルの解析 / key bacteriaの同定 / 抗菌剤併用便移植療法 / A- FMT / 腸内細菌叢 / 抗生剤療法 / バクテロイデテス / 抗生剤 / 腸内フローラ |
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| Outline of Final Research Achievements |
This was an open label, non-randomized, prospective control study. These patients were diagnosed with active UC, with a Lichtiger’s Clinical Activity Index (CAI) of 5 or more, or with an endoscopic Mayo clinic score of 1 or more, between July 2014 and March 2017. Results: Patients with mild-to-severe active UC (n=55 A-FMT; n=37 AFM) were included in this assessment. Seventy-nine patients completed this assessment (n=46 A-FMT; n=32 AFM). At 4 weeks after treatment, clinical responses in A-FMT were observed in 31 patients {Per Protocol Set (PPS):67.3%}, which was higher than in AFM (PPS:56.2%). Clinical remission was also observed to be higher in A-FMT than in AFM (A-FMT41.3%, AFM18.7%; p=0.06). Endoscopic sum score was associated with clinical responses (Responders7.5±3.2, Non-responders5.1±3.6; p=0.03), and clinical responses and remission were significantly higher in proctitis than in other types of colitis in A-FMT (n=38, 8; p=0.03, p=0.005).
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| Academic Significance and Societal Importance of the Research Achievements |
若年者が多いUCの場合、低年齢から強い副作用のある免疫抑制剤、ステロイド等が長期使用されるケースが多く、副作用の少ない根本的治療が強く望まれている。難治性UCにおいて、従来の免疫抑制を中心にした治療は効果が非常に乏しく、易感染性、薬剤抵抗性、血液悪性腫瘍の発生など長期投与に対する安全性も確立されていない。当研究で確立を目指すA-FMT療法は、既存の薬剤治療で問題となるさまざまな副作用は除外され、その安全性は高い。UCだけでなく疾患に関与する菌種の同定と、菌種定着のメカニズムの解明はプレバイオティクス、プロバイオティクスの個別化応用にも直結する。
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