Fecal microbiota transplantation: therapeutical approaches and regulatory framework
Since Ilya Metchnikoff’s studies, both medical science and clinical practice have accumulated a large amount of evidence that human intestinal microbiota possesses a unique characteristics for our existence. However, only recently, scientists have achieved the actual breakthrough in this field of hu...
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-02-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
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| Online Access: | https://www.biopreparations.ru/jour/article/view/10 |
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| author | A. N. Vasilyev D. V. Goryachev E. V. Gavrishina R. R. Niyazov Yu. A. Seliverstov A. V. Digtyar |
| author_facet | A. N. Vasilyev D. V. Goryachev E. V. Gavrishina R. R. Niyazov Yu. A. Seliverstov A. V. Digtyar |
| author_sort | A. N. Vasilyev |
| collection | DOAJ |
| description | Since Ilya Metchnikoff’s studies, both medical science and clinical practice have accumulated a large amount of evidence that human intestinal microbiota possesses a unique characteristics for our existence. However, only recently, scientists have achieved the actual breakthrough in this field of human physiology, and we start to understand the precise mechanisms of the complex interplay of microbial activity with human homeostasis and discover numerous new functions of intestinal microbes. In this regard, a novel medical technology evolves since 1958, so called fecal microbiota transplantation (FMT), which is the administration of donor feces to the patients suffering from different kinds of diseases. Such infusion of donor feces restores the natural balance of gut commensal germs. FMT is most efficacious in severe or recurrent Clostridium difficile infection. FMT has been also reported to cure diarrhea and constipation caused by different conditions, such as multiple sclerosis, Crohn ’s disease etc. In the U.S. and Canada as well as in other countries FMT is of uttermost interest of not merely clinical practitioners but lately also of regulatory authorities. The paper also addresses the possibility of application the Russian pharmaceutical legislation to FMT. |
| format | Article |
| id | doaj-art-5aa7e4fa05f04e6a82851d73733c556d |
| institution | Kabale University |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| publishDate | 2018-02-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj-art-5aa7e4fa05f04e6a82851d73733c556d2025-08-20T03:43:15ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-02-0102152310Fecal microbiota transplantation: therapeutical approaches and regulatory frameworkA. N. Vasilyev0D. V. Goryachev1E. V. Gavrishina2R. R. Niyazov3Yu. A. Seliverstov4A. V. Digtyar5Federal State Budgetary Institution «Scientific Center on Expertise of Medical Application Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Center on Expertise of Medical Application Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Center on Expertise of Medical Application Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Center on Expertise of Medical Application Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Scientific Institution «Research Center of Neurology», Russian Academy of SciencesFederal State Budgetary Institution «Scientific Center on Expertise of Medical Application Products» of the Ministry of Health of the Russian FederationSince Ilya Metchnikoff’s studies, both medical science and clinical practice have accumulated a large amount of evidence that human intestinal microbiota possesses a unique characteristics for our existence. However, only recently, scientists have achieved the actual breakthrough in this field of human physiology, and we start to understand the precise mechanisms of the complex interplay of microbial activity with human homeostasis and discover numerous new functions of intestinal microbes. In this regard, a novel medical technology evolves since 1958, so called fecal microbiota transplantation (FMT), which is the administration of donor feces to the patients suffering from different kinds of diseases. Such infusion of donor feces restores the natural balance of gut commensal germs. FMT is most efficacious in severe or recurrent Clostridium difficile infection. FMT has been also reported to cure diarrhea and constipation caused by different conditions, such as multiple sclerosis, Crohn ’s disease etc. In the U.S. and Canada as well as in other countries FMT is of uttermost interest of not merely clinical practitioners but lately also of regulatory authorities. The paper also addresses the possibility of application the Russian pharmaceutical legislation to FMT.https://www.biopreparations.ru/jour/article/view/10fecal microbiota transplantationfmtgut microbiotaclostridium difficilemultiple sclerosisprobioticantibioticpharmaceutical legislationкишечная микробиотатрансплантация кишечной микробиотыclostridium difficileрассеянный склерозпробиотикэубиотикантибиотикзаконодательство в сфере обращения лекарственных средств |
| spellingShingle | A. N. Vasilyev D. V. Goryachev E. V. Gavrishina R. R. Niyazov Yu. A. Seliverstov A. V. Digtyar Fecal microbiota transplantation: therapeutical approaches and regulatory framework Биопрепараты: Профилактика, диагностика, лечение fecal microbiota transplantation fmt gut microbiota clostridium difficile multiple sclerosis probiotic antibiotic pharmaceutical legislation кишечная микробиота трансплантация кишечной микробиоты clostridium difficile рассеянный склероз пробиотик эубиотик антибиотик законодательство в сфере обращения лекарственных средств |
| title | Fecal microbiota transplantation: therapeutical approaches and regulatory framework |
| title_full | Fecal microbiota transplantation: therapeutical approaches and regulatory framework |
| title_fullStr | Fecal microbiota transplantation: therapeutical approaches and regulatory framework |
| title_full_unstemmed | Fecal microbiota transplantation: therapeutical approaches and regulatory framework |
| title_short | Fecal microbiota transplantation: therapeutical approaches and regulatory framework |
| title_sort | fecal microbiota transplantation therapeutical approaches and regulatory framework |
| topic | fecal microbiota transplantation fmt gut microbiota clostridium difficile multiple sclerosis probiotic antibiotic pharmaceutical legislation кишечная микробиота трансплантация кишечной микробиоты clostridium difficile рассеянный склероз пробиотик эубиотик антибиотик законодательство в сфере обращения лекарственных средств |
| url | https://www.biopreparations.ru/jour/article/view/10 |
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