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Evaluating the efficacy of synbiotics in the treatment of patients with anorexia nervosa: a randomised controlled trial.

Research Project

Project/Area Number 20K16552
Research Category

Grant-in-Aid for Early-Career Scientists

Allocation TypeMulti-year Fund
Review Section Basic Section 52010:General internal medicine-related
Research InstitutionKyushu University

Principal Investigator

Hata Tomokazu  九州大学, 大学病院, 助教 (10535983)

Project Period (FY) 2020-04-01 – 2024-03-31
Project Status Completed (Fiscal Year 2023)
Budget Amount *help
¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000)
Fiscal Year 2022: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2021: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2020: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Keywords神経性やせ症 / 腸内細菌 / シンバイオティクス / 尿毒症毒素 / メタボローム解析
Outline of Research at the Start

申請者はこれまでの研究で、神経性やせ症患者では“dysbiosis”と呼ばれる腸内細菌叢の異常が生じており、その“dysbiosis”が体重増加不良や精神症状に関与することを示唆する結果を得ている。本研究では、その“dysbiosis”を是正するためにシンバイオティクスを投与し、症状の改善効果をもたらすかを科学的に検証する。方法として、プラセボ投与を対照とするランダム化比較試験を行う。

Outline of Final Research Achievements

The aim of this study was to scientifically verify the effect of symbiotics (‘SynB’) on the correction of dysbiosis in patients with anorexia nervosa (‘AN’). As a preliminary experiment, AN patients were treated with SynB; a trend towards greater weight gain per cumulative energy intake was observed in patients treated with SynB. Subsequently, the subject of this study, a randomised controlled trial with placebo administration, was initiated; due to the intermittent spread of COVID-19 infection, it was not possible to collect a valid sample size for analysis at the end of FY2023. Due to the double-blind nature of the study, it is unclear which group is the SynB group, but differences between groups have been observed in feeding efficiency and other parameters.

Academic Significance and Societal Importance of the Research Achievements

現状、有効なサンプル数に到達していないため、二重盲検試験の盲検化を解除していない。どちらの群がSynB群か不明であるが、摂食効率などに群間差を認めており、SynB投与が摂食効率に影響を及ぼすことが示唆される。今後、学術的意義として、腸内細菌叢や各種代謝物がAN患者にどのような影響を及ぼしているか明確になると考える。また、社会的意義として、病状改善につながる新しい食事療法の提案が可能となると考える。

Report

(5 results)
  • 2023 Annual Research Report   Final Research Report ( PDF )
  • 2022 Research-status Report
  • 2021 Research-status Report
  • 2020 Research-status Report
  • Research Products

    (6 results)

All 2024 2023 Other

All Journal Article (2 results) (of which Peer Reviewed: 2 results,  Open Access: 2 results) Presentation (3 results) Remarks (1 results)

  • [Journal Article] Dietary supplementation with 1-kestose induces altered locomotor activity and increased striatal dopamine levels with a change in gut microbiota in male mice.2023

    • Author(s)
      Altaisaikhan A, Yoshihara K, Hata T, Miyata N, Asano Y, Suematsu T, Kadota Y, Sudo N.
    • Journal Title

      Physiol Rep.

      Volume: 11(23) Issue: 23

    • DOI

      10.14814/phy2.15882

    • Related Report
      2023 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Persistence of gut dysbiosis in individuals with anorexia nervosa.2023

    • Author(s)
      Morisaki Y, Miyata N, Nakashima M, Hata T, Takakura S, Yoshihara K, Suematsu T, Nomoto K, Miyazaki K, Tsuji H, Sudo N.
    • Journal Title

      PLoS One.

      Volume: 18(12) Issue: 12 Pages: e0296037-e0296037

    • DOI

      10.1371/journal.pone.0296037

    • Related Report
      2023 Annual Research Report
    • Peer Reviewed / Open Access
  • [Presentation] 腸内細菌と神経性やせ症の関連から考える栄養療法の可能性2024

    • Author(s)
      波夛 伴和
    • Organizer
      第63回 日本心身医学会 九州地方会
    • Related Report
      2023 Annual Research Report
  • [Presentation] 神経性やせ症における腸内細菌叢の役割2023

    • Author(s)
      波夛 伴和
    • Organizer
      第64回 日本心身医学会および学術講演会
    • Related Report
      2023 Annual Research Report
  • [Presentation] 腸内細菌-脳腸相関と摂食障害2023

    • Author(s)
      波夛 伴和
    • Organizer
      第39回 日本ストレス学会
    • Related Report
      2023 Annual Research Report
  • [Remarks] 臨床研究情報ポータルサイト

    • URL

      https://rctportal.niph.go.jp/detail/jr?trial_id=jRCTs071200008

    • Related Report
      2020 Research-status Report

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Published: 2020-04-28   Modified: 2025-01-30  

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