. 2022 Mar 7:27:100906.

doi: 10.1016/j.conctc.2022.100906. eCollection 2022 Jun.

Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety

Christine K Liu^{1

2

3

4}, Janet Seo⁵, Vassiliki Pravodelov¹, Susan Frazier¹, Marsha Guy¹, Katherine Concilio¹, Rossana Lau-Ng¹, Gary Brandeis^{1

6}, Jon Watson⁷, Jeannette van der Velde⁷, Scott W Olesen⁷, Shrish Budree⁸, Mary Njenga⁷, Zain Kassam⁸, Majdi Osman⁸

Affiliations

¹ Section of Geriatrics, Department of Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USA.
² Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.
³ Section of Geriatrics, Division of Primary Care and Population Health, Stanford University School of Medicine, Stanford, CA, USA.
⁴ Geriatric Research and Education Clinical Center, Veteran Affairs Palo Alto Health Care System, Palo Alto, CA, USA.
⁵ Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁶ Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁷ OpenBiome, Cambridge, MA, USA.
⁸ Finch Therapeutics, Somerville, MA, USA.

PMID: 35299780
PMCID: PMC8921299
DOI: 10.1016/j.conctc.2022.100906

Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety

Christine K Liu et al. Contemp Clin Trials Commun. 2022.

. 2022 Mar 7:27:100906.

doi: 10.1016/j.conctc.2022.100906. eCollection 2022 Jun.

Authors

Affiliations

¹ Section of Geriatrics, Department of Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USA.
² Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.
³ Section of Geriatrics, Division of Primary Care and Population Health, Stanford University School of Medicine, Stanford, CA, USA.
⁴ Geriatric Research and Education Clinical Center, Veteran Affairs Palo Alto Health Care System, Palo Alto, CA, USA.
⁵ Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁶ Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁷ OpenBiome, Cambridge, MA, USA.
⁸ Finch Therapeutics, Somerville, MA, USA.

PMID: 35299780
PMCID: PMC8921299
DOI: 10.1016/j.conctc.2022.100906

Abstract

Introduction: Antibiotic resistant bacterial infections (ARBIs) are extremely common in nursing home residents. These infections typically occur after a course of antibiotics, which eradicate both pathological and beneficial organisms. The eradication of beneficial organisms likely facilitates subsequent ARBIs. Autologous fecal microbiota transplant (aFMT) has been proposed as a potential treatment to reduce ARBIs in nursing home residents. Our objective was to determine the feasibility and safety of aFMT in a nursing home population.

Methods: Pilot clinical trial. We evaluated feasibility as total number of stool samples collected for aFMT production and safety as the number and relatedness of serious (SAE) and non-serious adverse events (AE).

Results: We screened 468 nursing home residents aged ≥18 years for eligibility; 67 enrolled, distributed among three nursing homes. Participants were 62.7% female and 35.8% Black. Mean age was 82.2 ± 8.5 years. Thirty-three participants underwent successful stool collection. Seven participants received antibiotics; four participants underwent aFMT. There were 40 SAEs (17 deaths) and 11 AEs. In the aFMT group, there were 3 SAEs (2 deaths) and 10 AEs. All SAEs and AEs were judged unrelated to the study intervention.

Conclusions: In this pilot study of aFMT in nursing home residents, less than half were able to provide adequate stool samples for aFMT. There were no related SAEs or AEs during the study. In sum, we conclude aFMT has limited feasibility in a nursing home population due to logistic and technical challenges but is likely safe.

Trial registration: ClinicalTrials.gov Identifier: NCT03061097.

Keywords: AE, adverse event; ARBI, antibiotic resistant bacterial infections; Elderly; FMT, fecal microbiota transplant; Fecal transplants; Microbiota; Nursing home; Older adults; SAE, serious adverse event; aFMT, autologous fecal microbiota transplant.

Published by Elsevier Inc.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Shrish Budree is a shareholder and employee of Finch Therapeutics. Zain Kassam is a shareholder of Finch Therapeutics.

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Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety

Affiliations

Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety

Authors

Affiliations

Abstract

Conflict of interest statement

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