| Project/Area Number |
18K05523
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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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| Review Section |
Basic Section 38050:Food sciences-related
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| Research Institution | Showa University |
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Principal Investigator |
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| Project Period (FY) |
2018-04-01 – 2024-03-31
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| Project Status |
Completed (Fiscal Year 2023)
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| Budget Amount *help |
¥4,420,000 (Direct Cost: ¥3,400,000、Indirect Cost: ¥1,020,000)
Fiscal Year 2020: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2019: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2018: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
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| Keywords | 食物アレルギー / 経口免疫療法 / 腸内細菌 / マイクロバイオーム / 鶏卵アレルギー / ビフィズス菌 / 無作為盲検化比較試験 / 乳酸菌 / プロバイオティクス / 食物繊維 / 耐性獲得 / 食物アレルギ / 減感作 / 二重盲検化比較試験 |
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| Outline of Final Research Achievements |
We conducted a randomised, double-blind, comparative study of patients undergoing hen's egg oral immunotherapy (OIT). Bifidobacteria and dietary fibre were administered to the intervention and non-intervention groups, respectively, during the course of OIT. Forty-one subjects were enrolled, 21 in the intervention group and 20 in the non-intervention group. Age was 6 (5-9) years, egg threshold was 1/32 of a hen's egg 31 patients were able to perform a food oral challenge test at week 48. Twenty were negative, 10 (63%) in the intervention group and 10 (75%) in the non-intervention group, with no significant differences. There were also 6 persistent non-responses in the intervention group and 3 in the non-intervention group, which did not differ significantly. In conclusion, bifidobacteria administration in OIT showed no apparent benefit in OIT outcomes.
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| Academic Significance and Societal Importance of the Research Achievements |
経口免疫療法は、現在食物アレルギー患者において唯一の治癒を期待できる取り組みである。一方で、経過中のアナフィラキシーを含めた症状誘発や、真の治癒の獲得（耐性獲得）が困難であるなどの課題を有している。様々な観点でこうした課題の解決に向けた取り組みが行われてきたが、その一つに腸内細菌の調整効果が期待されてきた。従来の報告では、その評価は定まっていないことが、本研究実施のきっかけとなった。
本研究はランダム化二重盲検比較試験であり、研究の質はもっと高い。本研究の成果として、経口免疫療法に対する乳酸菌製剤の介入は効果的でないことが示され、今後の本研究分野の進展に大きく寄与することができた。
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