Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety
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 subse...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-06-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865422000230 |
| _version_ | 1818242653867737088 |
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| author | Christine K. Liu Janet Seo Vassiliki Pravodelov Susan Frazier Marsha Guy Katherine Concilio Rossana Lau-Ng Gary Brandeis Jon Watson Jeannette van der Velde Scott W. Olesen Shrish Budree Mary Njenga Zain Kassam Majdi Osman |
| author_facet | Christine K. Liu Janet Seo Vassiliki Pravodelov Susan Frazier Marsha Guy Katherine Concilio Rossana Lau-Ng Gary Brandeis Jon Watson Jeannette van der Velde Scott W. Olesen Shrish Budree Mary Njenga Zain Kassam Majdi Osman |
| author_sort | Christine K. Liu |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T13:48:39Z |
| format | Article |
| id | doaj.art-6d3bac4bcab343f880d1db9b145ca0e8 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-12T13:48:39Z |
| publishDate | 2022-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-6d3bac4bcab343f880d1db9b145ca0e82022-12-22T00:22:36ZengElsevierContemporary Clinical Trials Communications2451-86542022-06-0127100906Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safetyChristine K. Liu0Janet Seo1Vassiliki Pravodelov2Susan Frazier3Marsha Guy4Katherine Concilio5Rossana Lau-Ng6Gary Brandeis7Jon Watson8Jeannette van der Velde9Scott W. Olesen10Shrish Budree11Mary Njenga12Zain Kassam13Majdi Osman14Section of Geriatrics, Department of Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USA; Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA; Section of Geriatrics, Division of Primary Care and Population Health, Stanford University School of Medicine, Stanford, CA, USA; Geriatric Research and Education Clinical Center, Veteran Affairs Palo Alto Health Care System, Palo Alto, CA, USA; Corresponding author. Section of Geriatrics, Division of Primary Care and Population Health, Stanford University School of Medicine, 1265 Welch Road, Stanford, CA, 94305, USA.Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USASection of Geriatrics, Department of Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USASection of Geriatrics, Department of Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USASection of Geriatrics, Department of Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USASection of Geriatrics, Department of Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USASection of Geriatrics, Department of Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USASection of Geriatrics, Department of Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USA; Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USAOpenBiome, Cambridge, MA, USAOpenBiome, Cambridge, MA, USAOpenBiome, Cambridge, MA, USAFinch Therapeutics, Somerville, MA, USAOpenBiome, Cambridge, MA, USAFinch Therapeutics, Somerville, MA, USAFinch Therapeutics, Somerville, MA, USAIntroduction: 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.http://www.sciencedirect.com/science/article/pii/S2451865422000230ElderlyOlder adultsFecal transplantsMicrobiotaNursing home |
| spellingShingle | Christine K. Liu Janet Seo Vassiliki Pravodelov Susan Frazier Marsha Guy Katherine Concilio Rossana Lau-Ng Gary Brandeis Jon Watson Jeannette van der Velde Scott W. Olesen Shrish Budree Mary Njenga Zain Kassam Majdi Osman Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety Contemporary Clinical Trials Communications Elderly Older adults Fecal transplants Microbiota Nursing home |
| title | Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety |
| title_full | Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety |
| title_fullStr | Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety |
| title_full_unstemmed | Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety |
| title_short | Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety |
| title_sort | pilot study of autologous fecal microbiota transplants in nursing home residents feasibility and safety |
| topic | Elderly Older adults Fecal transplants Microbiota Nursing home |
| url | http://www.sciencedirect.com/science/article/pii/S2451865422000230 |
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