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Vaginal Microbiota Transplantation: The Next Frontier.
- Source :
-
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics [J Law Med Ethics] 2019 Dec; Vol. 47 (4), pp. 555-567. - Publication Year :
- 2019
-
Abstract
- The success of fecal microbiota transplantation (FMT) as a treatment for Clostrioides difficile infection (CDI) has stirred excitement about the potential for microbiota transplantation as a therapy for a wide range of diseases and conditions. In this article, we discuss vaginal microbiota transplantation (VMT) as "the next frontier" in microbiota transplantation and identify the medical, regulatory, and ethical challenges related to this nascent field. We further discuss what we anticipate will be the first context for testing VMT in clinical trials, prevention of the recurrence of a condition referred to as bacterial vaginosis (BV). We also compare clinical aspects of VMT with FMT and comment on how VMT may be similar to or different from FMT in ways that may affect research design and regulatory decisions.
- Subjects :
- Clinical Trials as Topic
Ethics, Research
Female
Government Regulation
Humans
Research Design
United States
United States Food and Drug Administration
Biological Therapy ethics
Biological Therapy methods
Biological Therapy trends
Body Fluids microbiology
Microbiota
Vagina microbiology
Vaginosis, Bacterial therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1748-720X
- Volume :
- 47
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
- Publication Type :
- Academic Journal
- Accession number :
- 31957577
- Full Text :
- https://doi.org/10.1177/1073110519897731