TY - JOUR
T1 - Challenges and costs of donor screening for fecal microbiota transplantations
AU - Bénard, M. lanie V.
AU - de Bruijn, Clara M. A.
AU - Fenneman, Aline C.
AU - Wortelboer, Koen
AU - Zeevenhoven, Judith
AU - Rethans, Bente
AU - Herrema, Hilde J.
AU - van Gool, Tom
AU - Nieuwdorp, Max
AU - Benninga, Marc A.
AU - Ponsioen, Cyriel Y.
N1 - Funding Information: MN is supported by a ZONMW VICI grant 2020 [09150182010020]. There were no other specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. The funders (ZONMW) had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The authors are grateful to all the potential stool donors who participated in the study. We thank research analyst Patricia Broekhuizen for the work she performed around coordinating and analysing the Dual Feces Tests. We thank Djuna de Jong for her support on screening donors. Lastly we thank Anouschka Komproe for assistance in data processing. Publisher Copyright: © 2022 Bénard et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2022/10/1
Y1 - 2022/10/1
N2 - BACKGROUND: The increasing interest to perform and investigate the efficacy of fecal microbiota transplantation (FMT) has generated an urge for feasible donor screening. We report our experience with stool donor recruitment, screening, follow-up, and associated costs in the context of clinical FMT trials. METHODS: Potential stool donors, aged between 18-65 years, underwent a stepwise screening process starting with an extensive questionnaire followed by feces and blood investigations. When eligible, donors were rescreened for MDROs and SARS-CoV-2 every 60-days, and full rescreening every 4-6 months. The costs to find and retain a stool donor were calculated. RESULTS: From January 2018 to August 2021, 393 potential donors underwent prescreening, of which 202 (51.4%) did not proceed primarily due to loss to follow-up, medication use, or logistic reasons (e.g. COVID-19 measures). 191 potential donors filled in the questionnaire, of which 43 (22.5%) were excluded. The remaining 148 candidates underwent parasitology screening: 91 (61.5%) were excluded, mostly due to Dientamoeba fragilis and/or high amounts of Blastocystis spp. After additional feces investigations 18/57 (31.6%) potential donors were excluded (mainly for presence of Helicobacter Pylori and ESBL-producing organisms). One donor failed serum testing. Overall, 38 out of 393 (10%) potential donors were enrolled. The median participation time of active stool donors was 13 months. To recruit 38 stool donors, €64.112 was spent. CONCLUSION: Recruitment of stool donors for FMT is challenging. In our Dutch cohort, failed eligibility of potential donors was often caused by the presence of the protozoa Dientamoeba fragilis and Blastocystis spp.. The exclusion of potential donors that carry these protozoa, especially Blastocystis spp., is questionable and deserves reconsideration. High-quality donor screening is associated with substantial costs.
AB - BACKGROUND: The increasing interest to perform and investigate the efficacy of fecal microbiota transplantation (FMT) has generated an urge for feasible donor screening. We report our experience with stool donor recruitment, screening, follow-up, and associated costs in the context of clinical FMT trials. METHODS: Potential stool donors, aged between 18-65 years, underwent a stepwise screening process starting with an extensive questionnaire followed by feces and blood investigations. When eligible, donors were rescreened for MDROs and SARS-CoV-2 every 60-days, and full rescreening every 4-6 months. The costs to find and retain a stool donor were calculated. RESULTS: From January 2018 to August 2021, 393 potential donors underwent prescreening, of which 202 (51.4%) did not proceed primarily due to loss to follow-up, medication use, or logistic reasons (e.g. COVID-19 measures). 191 potential donors filled in the questionnaire, of which 43 (22.5%) were excluded. The remaining 148 candidates underwent parasitology screening: 91 (61.5%) were excluded, mostly due to Dientamoeba fragilis and/or high amounts of Blastocystis spp. After additional feces investigations 18/57 (31.6%) potential donors were excluded (mainly for presence of Helicobacter Pylori and ESBL-producing organisms). One donor failed serum testing. Overall, 38 out of 393 (10%) potential donors were enrolled. The median participation time of active stool donors was 13 months. To recruit 38 stool donors, €64.112 was spent. CONCLUSION: Recruitment of stool donors for FMT is challenging. In our Dutch cohort, failed eligibility of potential donors was often caused by the presence of the protozoa Dientamoeba fragilis and Blastocystis spp.. The exclusion of potential donors that carry these protozoa, especially Blastocystis spp., is questionable and deserves reconsideration. High-quality donor screening is associated with substantial costs.
UR - http://www.scopus.com/inward/record.url?scp=85140283607&partnerID=8YFLogxK
U2 - https://doi.org/10.1371/journal.pone.0276323
DO - https://doi.org/10.1371/journal.pone.0276323
M3 - Article
C2 - 36264933
SN - 1932-6203
VL - 17
SP - e0276323
JO - PLOS ONE
JF - PLOS ONE
IS - 10 October
M1 - e0276323
ER -