Ann Lab Med.  2021 Jul;41(4):424-428. 10.3343/alm.2021.41.4.424.

Laboratory Aspects of Donor Screening for Fecal Microbiota Transplantation at a Korean Fecal Microbiota Bank

Affiliations
  • 1Department of Laboratory Medicine and Research Institute of Bacterial Resistance, Yonsei University College of Medicine, Seoul, Korea
  • 2Microbiotix Corporation, Seoul, Korea
  • 3Brain Korea 21 Plus Project for Medical Science, Yonsei University College of Medicine, Seoul, Korea

Abstract

Fecal microbiota transplantation (FMT) is a widely accepted alternative therapy for Clostridioides difficile infection and other gastrointestinal disorders. Thorough donor screening is required as a safety control measure to minimize transmission of infectious agents in FMT. We report the donor screening process and outcomes at a fecal microbiota bank in Korea. From August 2017 to June 2020, the qualification of 62 individuals as FMT donors was evaluated using clinical assessment and laboratory tests. Forty-six (74%) candidates were excluded after clinical assessment; high body mass index ( > 25) was the most common reason for exclusion, followed by atopy, asthma, and allergy history. Four of the remaining 16 (25%) candidates failed to meet laboratory test criteria, resulting in a 19% qualification rate. FMT donor re-qualification was conducted monthly as an additional safety control measure, and only three (5%) candidates were eligible for repeated donation. As high prevalence of multidrug-resistant organisms (55%) and Helicobacter pylori (44%) were detected in qualified donors during the screening, a urea breath test was added to the existing protocol. The present results emphasize the importance of implementing a donor re-qualification system to minimize risk factors not identified during initial donor screening.

Keyword

Korea; Fecal microbiota transplantation; Fecal microbiota bank; Donor screening

Figure

  • Fig. 1 Fecal microbiota transplantation donor screening process and outcomes. *Some donor candidates met multiple criteria for exclusion. Abbreviations: BMI, body mass index; GI, gastrointestinal; ANA, antinuclear antibody; ESR, erythrocyte sedimentation rate; MDRO, multidrug-resistant organisms; ESBL, extended spectrum β-lactamase; VRE, vancomycin-resistant enterococci; UBT, urea breath test; BUN, blood urea nitrogen.


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