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Tytuł:
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Long-term Safety of Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection.
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Autorzy:
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Saha S; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Mara K; Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.
Pardi DS; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Khanna S; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. Electronic address: .
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Źródło:
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Gastroenterology [Gastroenterology] 2021 May; Vol. 160 (6), pp. 1961-1969.e3. Date of Electronic Publication: 2021 Jan 11.
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Typ publikacji:
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Journal Article; Research Support, N.I.H., Extramural
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Język:
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English
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Imprint Name(s):
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Publication: Philadelphia, PA : W.B. Saunders
Original Publication: Baltimore.
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MeSH Terms:
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Clostridioides difficile*
Constipation/*etiology
Diarrhea/*etiology
Enterocolitis, Pseudomembranous/*therapy
Fecal Microbiota Transplantation/*adverse effects
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anti-Bacterial Agents/therapeutic use ; Diabetes Mellitus/epidemiology ; Dyslipidemias/epidemiology ; Enterocolitis, Pseudomembranous/complications ; Enterocolitis, Pseudomembranous/drug therapy ; Fecal Microbiota Transplantation/statistics & numerical data ; Female ; Humans ; Inflammatory Bowel Diseases/complications ; Inflammatory Bowel Diseases/epidemiology ; Male ; Middle Aged ; Pneumonia/epidemiology ; Prospective Studies ; Recurrence ; Risk Factors ; Sepsis/epidemiology ; Surveys and Questionnaires ; Time Factors ; Urinary Tract Infections/epidemiology ; Weight Gain ; Young Adult
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Grant Information:
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UL1 TR002377 United States TR NCATS NIH HHS; U01 FD005938 United States FD FDA HHS; UL1 TR000135 United States TR NCATS NIH HHS
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Contributed Indexing:
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Keywords: Abdominal Pain; Adverse Event; Diarrhea; Microbiome; Outcome
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Substance Nomenclature:
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0 (Anti-Bacterial Agents)
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Entry Date(s):
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Date Created: 20210114 Date Completed: 20210907 Latest Revision: 20211229
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Update Code:
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20240105
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DOI:
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10.1053/j.gastro.2021.01.010
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PMID:
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33444573
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Background: Fecal microbiota transplantation (FMT) is highly effective for treating recurrent Clostridioides difficile infection (CDI), with emerging data on intermediate and long-term safety.
Methods: A prospective survey-based study was conducted (September 2012-June 2018) in patients undergoing FMT for recurrent CDI. Data on demographics and comorbidities were abstracted from medical records. Patients were contacted at 1 week, 1 month, 6 months, 1 year (short-term), and ≥2 years post-FMT (long-term). Symptoms and new medical diagnoses were recorded at each time point. Data were weighted to account for survey nonresponse bias. Multivariate logistic regression models for adverse events were built using age (per 10-year increment), sex, time of survey, and comorbidities. P < .05 was considered statistically significant.
Results: Overall, 609 patients underwent FMT; median age was 56 years (range, 18-94), 64.8% were women, 22.8% had inflammatory bowel disease (IBD). At short-term follow-up (n = 609), >60% of patients had diarrhea and 19%-33% had constipation. At 1 year, 9.5% reported additional CDI episodes. On multivariable analysis, patients with IBD, dialysis-dependent kidney disease, and multiple FMTs had higher risk of diarrhea; risk of constipation was higher in women and lower in IBD (all P < .05). For long-term follow-up (n = 447), median time of follow-up was 3.7 years (range, 2.0-6.8). Overall, 73 new diagnoses were reported: 13% gastrointestinal, 10% weight gain, 11.8% new infections (all deemed unrelated to FMT). Median time to infections was 29 months (range, 0-73) post-FMT.
Conclusion: FMT appears safe with low risk of transmission of infections. Several new diagnoses were reported, which should be explored in future studies.
(Copyright © 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.)
Comment in: Gastroenterology. 2021 Oct;161(4):1344. (PMID: 34090885)
Comment in: Gastroenterology. 2021 Oct;161(4):1345. (PMID: 34174246)
