Vaginal Microbiota Transplantation: The Next Frontier

Kevin DeLong; Fareeha Zulfiqar; Diane E Hoffmann; Anita J Tarzian; Laura M Ensign

doi:10.1177/1073110519897731

Vaginal Microbiota Transplantation: The Next Frontier

J Law Med Ethics. 2019 Dec;47(4):555-567. doi: 10.1177/1073110519897731.

Authors

Kevin DeLong¹, Fareeha Zulfiqar¹, Diane E Hoffmann¹, Anita J Tarzian¹, Laura M Ensign¹

Affiliation

¹ Kevin DeLong, Ph.D., is at the Center for Nanomedicine, Department of Ophthalmology, The Wilmer Eye Institute, Johns Hopkins University School of Medicine. Fareeha Zulfiqar, Ph.D., is at the Center for Nanomedicine, Department of Ophthalmology, The Wilmer Eye Institute, Johns Hopkins University School of Medicine. Diane E. Hoffmann, J.D., is at the University of Maryland Francis King Carey School of Law. Anita J. Tarzian, Ph.D., R.N., is at the University of Maryland Francis King Carey School of Law and the School of Nursing. Laura M. Ensign, Ph.D., is at the Center for Nanomedicine, Department of Ophthalmology, The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Departments of Gynecology and Obstetrics, Infectious Diseases, Pharmacology and Molecular Sciences, and Oncology, Johns Hopkins University School of Medicine, and the Departments of Chemical & Biomolecular Engineering and Biomedical Engineering, Johns Hopkins University.

PMID: 31957577
DOI: 10.1177/1073110519897731

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.

MeSH terms

Biological Therapy / ethics*
Biological Therapy / methods*
Biological Therapy / trends*
Body Fluids / microbiology*
Clinical Trials as Topic
Ethics, Research
Female
Government Regulation
Humans
Microbiota*
Research Design
United States
United States Food and Drug Administration
Vagina / microbiology*
Vaginosis, Bacterial / therapy*