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Fecal microbiota transplantation and Clostridioides difficile infection among privately insured patients in the United States

Abstract

Background

Clostridioides difficile infection (CDI) may be rising in severity in the US over the past decade and its treatment landscape is changing given the recent adoption of fecal microbiota transplantation (FMT)

Methods

We built a retrospective observational cohort using a database of a national care-plan containing medical claims of over 50 million individuals between 2008 and 2019. We used International Classification of Disease (ICD) and prescription data to identify patients with CDI. We estimated trends in disease burden and FMT use, and evaluated complications post FMT using a phenome-wide association approach.

Results

We identified 38,396 patients with CDI; the median age was 60 years (IQR 45–74) and 60% were female (n = 23,374). The rate of CDI increased from 33.4 to 69.46 cases per 100,000 person-years between 2008 and 2015, and stabilized from 2015 to 2019 (increase of 4.77 cases per 100,000 person-years per year, 95% CI 3.55–5.98 prior to 2015 vs. 2.01 95% CI − 10.16 to 14.18 after 2015). Of the 7715 patients with recurrent CDI, 407 patients (5%) underwent FMT. Gastrointestinal complications were increased within 1 month post FMT (OR 99.60, p < 0.001). Sepsis was identified in two individuals (0.49% 95% CI 0.05–1.7%) within the first month post FMT. The risk of CDI recurrence significantly decreased post FMT compared with anti-CDI antibiotics in the multivariable model (raw-recurrence rate 9.8% vs 36%, aOR = 0.21, 95% CI 0.12–0.53, p < 0.001).

Conclusion

We show that FMT is strongly associated with a decrease in CDI recurrence compared with the usual care with generally mild complications for up to 2 years.

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Funding

This study was funded by the T15LM007092 Grant (JH), Biomedical Informatics and Data Science Research Training Program (PIs: Dr. Alexa T. McCray and Dr. Nils Gehlenborg) and by an NIH/BD2K award K01 ES026835 (MF). The funding source of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

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Correspondence to Maha R. Farhat.

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Dr. Fox reports personal fees from Aetna, outside of the submitted work, otherwise we declare that we have no conflicts of interest.

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El Halabi, J., Palmer, N., Fox, K. et al. Fecal microbiota transplantation and Clostridioides difficile infection among privately insured patients in the United States. J Gastroenterol (2021). https://doi.org/10.1007/s00535-021-01822-y

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Keywords

  • Clostridioides difficile
  • Fecal microbiota transplantation
  • Biomedical informatics