Introduction: The Promise and Challenges of Microbiome-Based Therapies

Abstract

Get full access to this article

View all access options for this article.

References

P.D.

Cani

, “Human Gut Microbiome: Hopes, Threats and Promises,” Gut 67, no. 9 (2018): 1716–1725.

Kim and

Chun , “Current Status and Future Promise of the Human Microbiome,” Pediatric Gastroenterology, Hepatology and Nutrition 16, no. 2 (2013): 71–79.

Song ,

Wang , and

Parian , et al., “Where Will Fecal Microbiota Transplantation Fit in the Treatment Algorithms for Crohn's Disease and Ulcerative Colitis: A Synthesis of Completed, Ongoing and Future Trials,” Gastroenterology 154, no. 1, Supp. (2018): S90.

W.J.

Lee ,

L.D.N.

Lattimer , and

Stephen , et al., “Fecal Microbiota Transplantation: A Review of Emerging Indications beyond Relapsing Clostridium difficile Toxin Colitis,” Gastroenterology and Hepatology 11, no. 1 (2015): 24–32.

Zhang

et al., “Efficacy and Safety of Fecal Microbiota Transplantation in Patients with Rheumatoid Arthritis Refractory to Methotrexate,” ClinicalTrials.gov, available at <https://clinicaltrials.gov/ct2/show/NCT03944096> (last visited September 25, 2019).

Zhang ,

Palazuelos-Munoz , and

E.M.

Balsells , et al., “Cost of Hospital Management of Clostridium difficile Infection in United States — a Meta-Analysis and Modelling Study,” BMC Infectious Diseases 16 (2016): 447. doi: 10.1186/s12879-016-1786-6.

L.C.

McDonald ,

D.N.

Gerding , and

Johnson , et al., “Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA),” Clinical Infectious Diseases 66, no.7 (2018): e1–e48.

Merrill

, “Big Pharma Embraces Microbiome Research; Partnering Poised to Follow,” The Pink Sheet (April 20, 1015).

I.A.

Myles ,

K.W.

Williams , and

J.D.

Reckhow , et al., “Transplantation of Human Skin Microbiota in Models of Atopic Dermatitis,” JCI Insight 1, no. 10 (2016): e86955, available at <https://dx.doi.org/10.1172/jci.insight.86955> (last visited September 25, 2019).

10.

Sohn

, “Skin Microbiota's Community Effort,” Nature 563 (2018): S91.

11.

M.M.

Nascimento

, “Oral Microbiota Transplant: A Potential New Therapy for Oral Diseases,” Journal of the California Dental Association 45, no. 10 (2017): 565–568.

12.

Anders

Mårtensson

et al., “Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis without Nasal Polyps (CRSsNP),” ClinicalTrials.gov, available at <https://clinical-trials.gov/ct2/show/NCT03122795> (last visited September 25, 2019).

13.

U.S. Food and Drug Administration, “Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies,” 78 Federal Register 42,965 (July 18, 2013).

14.

U.S. Food and Drug Administration, “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies, March 2016,” available at <https://www.fda.gov/media/96562/download> (last visited September 25, 2019).

15.

Id.

16.

National Institutes for Allergies and Infectious Diseases, Grant No. R21AI119633.

17.

The co-investigators included

Diane E.

Hoffmann

(PI) School of Law;

Francic

Palumbo , School of Pharmacy;

Jacques

Ravel1 , School of Medicine; and

Mary-Clair

Roghman and

Eric

von Rosenvinge , School of Medicine and Veteran Affairs Maryland Health Care System, Baltimore.

18.

D.E.

Hoffmann ,

F.B.

Palumbo , and

Ravel , et al., “Improving Regulation of Microbiota Transplants,” Science 358, no. 6369 (2017): 1390–1391.

19.

Khoruts ,

D.E.

Hoffmann , and

F.B.

Palumbo , “The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 482-504.

20.

Ossorio and

Zhou , “FMT and Microbial Medical Products: Generating High-Quality Evidence through Good Governance,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 505-523.

21.

Scheeler

, “Where Stool is a Drug: International Approaches to Regulating the use of Fecal Microbiota for Transplantation,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 524-540.

22.

T.S.

Murray and

Herbst , “The Ethics of Fecal Microbiota Transplant as a Tool for Antimicrobial Stewardship Programs,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 541-554.

23.

DeLong

et al., “Vaginal, “Microbiota Transplantation: The Next Frontier,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 555-567.

24.

Mueller

et al., “Bacterial Baptism: Scientific, Medical and Regulatory Issues Raised by Vaginal Seeding of C-Section-Born Babies,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 568-578.