关于菌群移植

ABOUT HMT

菌群移植(HMT)简介
菌群移植(HMT:Human Microbiota Transplantation或FMT),指将健康供体的肠道菌群通过智能肠菌处理系统制成混悬液或胶囊,移植到患者肠道内,通过重建患者正常功能的肠道微生态以实现其肠道及肠道外疾病的治疗。

Precision Microbiota Transplantation Therapy, PMTT

Precision Microbiota Transplantation Therapy, PMTT

History of Microbiota Transplantation

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Ancient China
1958
1989
2012
2013
2017
2018
2019
2020
2022
2023
2024
2025
2026

About 1,700 years ago, Ge Hong's Zhouhou Beiji Fang from the Eastern Jin dynasty provided the earliest known record of treating disease with clarified human fecal suspension.

Li Shizhen's Compendium of Materia Medica from the Ming dynasty also recorded more than twenty therapies using human feces.

The first Western report described FMT for pseudomembranous colitis.

Bennet et al. published the first report in The Lancet on FMT for ulcerative colitis.

FMT was named one of the top ten advances in gastroenterology in 2012, and Hamilton et al. published the first report of FMT for recurrent Clostridioides difficile infection.

A key medical milestone: FMT was incorporated into FDA guidance, and Science and Time named it one of the top ten breakthroughs in biomedicine.

FMT was ranked the top medical innovation of the year by Cleveland Clinic.

The Expert Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease was approved by the Guangzhou Municipal Development and Reform Commission and assigned an official billing code.

The Regulations on the Clinical Application of New Biomedical Technologies classified microbiota transplantation as a medium- to low-risk new biomedical technology.

The Chinese Expert Consensus on the Establishment and Clinical Application of Standardized Microbiota Transplantation Methodology was published.

The Shanghai Technical Management Specification for Microbiota Transplantation was issued, and billing codes were available in 14 provinces.

The Institute of Hospital Administration of the National Health Commission issued the Chinese Expert Consensus on the Clinical Application and Management of Intestinal Microbiota Transplantation. Shanghai officially approved a billing code for intestinal microbiota transplantation, marking the nationwide start of standardized industry management.

The National Health Commission, National Administration of Traditional Chinese Medicine, and National Disease Control and Prevention Administration jointly issued the National Technical Specifications for Medical Service Items (2023 Edition). Intestinal microbiota transplantation was formally incorporated into the national medical-service specification system, and 18 provinces and municipalities had issued institutional billing codes for the technology.

Drafting of China's first national standard for intestinal microbiota transplantation was officially launched during the China International Import Expo. The Chinese Expert Consensus on Intestinal Microbiota Transplantation for Children with Autism Spectrum Disorder (2024 Edition) was published, extending clinical applications from intestinal diseases to neurodevelopmental disorders.

The National Healthcare Security Administration issued the Guidelines for Establishing Medical Service Price Items for the Digestive System (Trial), incorporating an intestinal microbiota transplantation fee into the unified national medical-service pricing framework. The Chinese Expert Consensus on the Clinical Management and Application of Adult Intestinal Microbiota Transplantation (2025 Edition) was also published, and billing-code coverage expanded to 21 provinces and municipalities.

State Council Order No. 818, the Regulations on the Clinical Research and Translational Application of New Biomedical Technologies, took effect. It clarified that conventional FMT using healthy donors and physical separation and extraction is outside the scope of the regulations and is recognized as a mature, routinely provided microbiota transplantation technology that compliant medical institutions nationwide may offer and bill for as a standard service.

菌群移植安全吗?
2019年《生物医学新技术临床应用管理条例》将菌群移植归为中低风险生物医学新技术,目前全世界已开展数十万例次的菌群移植,极少有严重不良反应的报道。截止2020年12月,在美国Clinical Trials.gov 网站上已经注册的菌群移植相关临床项目多达379项,中国已开展62项菌群移植临床研究,其中大陆54项,香港7项,台湾1项,完成了总数高达60000例次的移植。这表明菌群移植技术已经在全球获得了广泛认可。

Clinical Applications of HMT

Clinical applications of HMT

Gastroenterology

  • Clostridioides difficile infection
  • Inflammatory bowel disease
  • Irritable bowel syndrome
  • Pouchitis
  • Pancreatitis
  • Functional constipation
  • Liver disease
  • Small intestinal bacterial overgrowth

Endocrinology

  • Metabolic syndrome
  • Obesity
  • Hypertension
  • Diabetes
  • Gout

Psychiatry

  • Anxiety disorder
  • Schizophrenia
  • Bipolar disorder
  • Depression
  • Bipolar depression
  • Autism

Neurology

  • Alzheimer's disease
  • Tourette syndrome
  • Epilepsy
  • Parkinson's disease
  • Multiple sclerosis

Oncology

  • Enhancement of immunotherapy
  • Immunotherapy-related colitis
  • Radiation enteritis

Dermatology

  • Psoriasis
  • Systemic lupus erythematosus

Urology / Organ Transplantation

  • Urinary tract infection
  • Cystitis

Infectious Diseases

  • AIDS
  • Multidrug-resistant bacterial infection

Hematology

  • Graft-versus-host disease

Global Consensus on HMT Clinical Application Guidelines

Date Journal Title Type Author Country
2013 The American Journal of GASTROENTEROLOGY Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections Guideline 华盛顿大学医学院 United States
2013 Clin Microbiol Infect European Society of Clinical Microbiology and Infectious Diseases (ESCMID): update of the treatment guidance document for Clostridium difficile infection (CDI) Guideline 欧洲临床微生物与感染性疾病学会(ESCMID,European Society of Clinical Microbiology and Infectious Diseases) Europe
2015 GESA官网 GESA Position Statement on Faecal Microbiota Transplant (FMT) Position Statement 澳大利亚胃肠病学会(GESA,Gastroenterological Seciety of Australia) Australia
2016 Chinese Journal of Microecology 关于儿童粪菌移植技术规范的共识 Consensus 中华预防医学会微生态学分会儿科学组 China
2017 Chinese Journal of Microecology 《儿童粪菌移植技术规范的共识》解读 Commentary 华中科技大学同济医学院附属同济医院 深圳市儿童医院呼吸科 China
2016 Chinese Journal of Microecology 中国消化道微生态调节剂临床应用 专家共识(2016版) Consensus 中华预防医学会微生态学分会 China
2017 Alimentary Pharmacology and Therapeutics Consensus report: faecal microbiota transfer - clinical applications and procedures Consensus 来自欧洲各国的知名专家 Europe
2017 胃肠病学 Commentary 南京医科大学附属南京医院消化科 China
2017 Gut European consensus conference on faecal microbiota transplantation in clinical practice Consensus 来自10个国家的28位专家共同提出 Europe
2017 胃肠病学和肝病学杂志 2016年欧洲粪菌移植共识介绍 Commentary 南京医科大学附属第一医院消化科 China
2017 协和医学杂志 中国成人艰难梭菌感染诊断和治疗专家共识 Consensus 中国医师协会检验医师分会感染性疾病检验医学专家委员会 China
2018 Chinese Journal of Digestion 炎症性肠病诊断与治疗的共识意见 Consensus 中华医学会消化病学分会炎症性肠病学组 China
2018 Gut The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guideline Guideline 英国胃肠病学会(BSG)联合医疗感染学会(HIS) United Kingdom
2018 中国肝脏病杂志 肝硬化肝性脑病诊疗指南 Guideline 中华医学会肝病学分会 China
2019 现代消化及介入诊疗 中国成人炎症性肠病合并艰难梭菌感染处理专家共识 Consensus 《现代消化及介入诊疗》杂志共识专家组 China
2019 实用肝脏病杂志 Guideline for diagnosis and treatment of liver failure Guideline 中华医学会感染病学分会肝衰竭与人工肝学组;中华医学会肝病学分会重型肝病与人工肝学组 China
2019 JPGN Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection and Other Conditions in Children: A Joint Position Paper From the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition Position Paper NASPGHAN/ESPGHAN North America
2019 Gut Scientific frontiers in faecal microbiota transplantation: joint document of Asia-Pacific Association of Gastroenterology (APAGE) and Asia- Pacific Society for Digestive Endoscopy (APSDE) Consensus 亚太胃肠病学协会(APAGE)和亚太消化内镜学会(APSDE) Asia-Pacific
2019 Neurogastroenterology & Motility European society of neurogastroenterology and motility guidelines on functional constipation in adults Guideline 欧洲神经胃肠病和运动学会 Europe
2019 Chinese Journal of Digestion 中国慢性便秘专家共识意见(2019,广州) Consensus 中华医学会消化病学分会胃肠动力学组功能性胃肠病协作组 China
2020 Gut Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice Guideline 24位澳大利亚专家 Australia
2020 Chinese Journal of Gastrointestinal Surgery 菌群移植适应证的选择和临床应用策略 Clinical Strategy 同济大学附属第十人民医院肠道微生态诊疗中心 同济大学医学院肠道疾病研究所 China
2020 Chinese Journal of Gastrointestinal Surgery 菌群移植标准化方法学的建立与临床应用中国专家共识 Consensus 中华医学会肠外肠内营养学分会 中国国际医疗保健促进交流会加速康复外科分会 中国微生态治疗创新联盟 上海预防医学会微生态专业委员会 China
2020 Chinese Journal of Gastrointestinal Surgery 菌群移植途径的选择与建立临床应用中国专家共识 Consensus 中华医学会肠外肠内营养学分会 中国国际医疗保健促进交流会加速康复外科分会 中国微生态治疗创新联盟 上海预防医学会微生态专业委员会 China
2020 Chinese Journal of Hematology 中国异基因造血干细胞移植治疗血液系统疾病专家共识(Ⅲ)—急性移植物抗宿主病(2020年版) Consensus 中华医学会血液学分会干细胞应用学组 China
2020 Chinese Journal of Microecology 中国微生态调节剂临床应用专家共识(2020版本) Consensus 中华预防医学会微生态学分会 China
2020 Chin Med J (Engl) Nanjing consensus on methodology of washed microbiota transplantation Consensus 菌群移植标准化研究组 China
2016 Dig Liver Dis Faecal microbiota transplantation in recurrent Clostridium difficile infection: Recommendations from the French Group of Faecal microbiota Transplantation Recommendations 法国粪菌移植小组(FGFT,French Group of Faecal microbiota Transplantation) France
2014 Can J Gastroenterol Hepatol Canadian Association of Gastroenterology position statement: Fecal microbiota transplant therapy Position Statement 加拿大胃肠病学协会(CAG,The Canadian Association of Gastroenterology) Canada

References

  • 1. Surawicz C M , Brandt L J , Binion D G , et al. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections.[J]. American Journal of Gastroenterology, 2013, 108(4):478-498.
  • 2. Debast S B,Bauer M P,Kuijper E J et al. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection.[J] .Clin Microbiol Infect, 2014, null: 1-26.
  • 3. Richard, Hunt, Paul, et al. Canadian Association of Gastroenterology position statement: Fecal microbiota transplant therapy[J]. Canadian Journal of Gastroenterology Journal Canadien De Gastroenterologie, 2014.
  • 4. www.gesa.com
  • 5. Sokol H , Galperine T , Kapel N , et al. Faecal microbiota transplantation in recurrent Clostridium difficile infection: Recommendations from the French Group of Faecal microbiota Transplantation[J]. Digestive and Liver Disease, 2016.
  • 6. 中华预防医学会微生态学分会儿科微生态学组. 关于儿童粪菌移植技术规范的共识[J]. 中国微生态学杂志, 2016, 28(04):479-481.
  • 6.1 黄志华, 郑跃杰. 《儿童粪菌移植技术规范的共识》解读[J]. 中国微生态学杂志, 2017(10).
  • 7. Chinese Society ofMicroecology, Chinese Preventive Medicine Association. 中国消化道微生态调节剂临床应用专家共识(2016版)[J]. 中国实用内科杂志, 2016.
  • 8. Consensus report: faecal microbiota transfer - clinical applications and procedures[J]. Alimentary Pharmacology and Therapeutics, 2017, 45(2):222-239.
  • 8.1 谈路轩, 李超, 张振玉. 欧洲《粪菌移植临床应用和操作共识报告》介绍[J]. 胃肠病学, 2017(10).
  • 9.1 李超, 谈路轩, 张馨梅,等. 2016年欧洲粪菌移植共识介绍[J]. 胃肠病学和肝病学杂志, 2017(9).
  • 9. Cammarota G , Ianiro G , Tilg H , et al. European consensus conference on faecal microbiota transplantation in clinical practice[J]. Gut, 2017, 67(1):569.
  • 10. 徐英春, 张曼. 中国成人艰难梭菌感染诊断和治疗专家共识[J]. 协和医学杂志, 2017(2).
  • 11. 吴开春, 梁洁, 冉志华,等. 炎症性肠病诊断与治疗的共识意见(2018年·北京)[J]. 中国实用内科杂志, 2018.
  • 12. The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines.[J]. The Journal of hospital infection, 2018.
  • 12.1 2018 BSG/HIS指南:粪菌移植治疗复发性难治性艰难梭菌感染和其它潜在疾病--中文翻译PDF(承葛生物技术支持团队)
  • 13. 中华医学会肝病学分会. 肝硬化肝性脑病诊疗指南[J]. 临床肝胆病杂志, 2018(10).
  • 14. 王浦, 王斯琪. 中国成人炎症性肠病合并艰难梭菌感染处理专家共识[J]. 现代消化及介入诊疗, 2019, 24(04):126-130.
  • 15. 中华医学会感染病学分会肝衰竭与人工肝学组, 中华医学会肝病学分会重型肝病与人工肝学组, 李兰娟,等. 肝衰竭诊治指南(2018年版)[J]. 现代医药卫生, 2018, 34(24):3897-3904.
  • 16. Davidovics Z H , Michail S , Nicholson M R , et al. Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection and Other Conditions in Children: A Joint Position Paper From the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition[J]. Journal of Pediatric Gastroenterology and Nutrition, 2019, 68(1):130-143.
  • 17. Kamm M A , Chan P K S , Zuo T , et al. Scientific frontiers in faecal microbiota transplantation: joint document of Asia-Pacific Association of Gastroenterology (APAGE) and Asia-Pacific Society for Digestive Endoscopy (APSDE)[J]. Gut, 2019:-.
  • 18. European society of neurogastroenterology and motility guidelines on functional constipation in adults[J]. Neurogastroenterology & Motility, 2020, 32(2).
  • 19. 中华医学会消化病学分会胃肠动力学组, 功能性胃肠病协作组. 中国慢性便秘专家共识意见(2019,广州)[J]. 中华消化杂志, 2019, 39(9):577-598.
  • 20. Haifer C , Kelly C R , Paramsothy S , et al. Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice[J]. Gut, 2020:gutjnl-2019-320260.
  • 21. 张雪莹, 陈启仪, 李宁,等. 菌群移植适应证的选择和临床应用策略[J]. 中华胃肠外科杂志 2020年23卷5期, 509-515页, MEDLINE ISTIC PKU CSCD, 2020.
  • 22. 中华医学会肠外肠内营养学分会, 中国国际医疗保健促进交流会加速康复外科分会, 中国微生态治疗创新联盟,等. 菌群移植标准化方法学的建立与临床应用中国专家共识[J]. 中华胃肠外科杂志, 2020, 23(Z1):5-13.
  • 23. 中华医学会肠外肠内营养学分会, 中国国际医疗保健促进交流会加速康复外科分会, 中国微生态治疗创新联盟,等. 菌群移植途径的选择与建立临床应用中国专家共识[J]. 中华胃肠外科杂志, 2020, 23(Z1):14-20.
  • 24. 黄晓军, 吴德沛. 中国异基因造血干细胞移植治疗血液系统疾病专家共识(Ⅲ)--急性移植物抗宿主病(2020年版)[J]. 中华血液学杂志, 2020(7):529-536.
  • 25. 中华预防医学会微生态学分会. 中国微生态调节剂临床应用专家共识(2020版)[J]. 中华临床感染病杂志, 2020, 13(04):241-256.
  • 26. Zhang F . Nanjing consensus on methodology of washed microbiota transplantation[J]. Chinese medical journal, 2020.