(P-BT-4) Capsule Based Fecal Microbiota Transplant Production: Quality Assurance and External Validation

Background/Case Studies: Fecal Microbiota Transplant (FMT) is recognized as a safe and effective treatment for recurring Clostridioides Difficile Infection (CDI). Our blood- and tissue transplant service manages production of FMT-products, which are later administered at gastroenterology departments. Conventionally FMT-products have been administered via endoscopy. Due to an increasing demand for FMT via oral capsules (cFMT), we began production of cFMT in 2021. All our FMT donors are voluntarily recruited from active blood and/or plasma donors. The screening protocol for FMT donors is described in the Danish national guideline for treatment of CDI. cFMT is produced in accordance with methods developed at a similar Danish FMT production center. Thus, the aim of this study was to assure the quality of our cFMT, in turn externally validating the similar center's cFMT production methods.

Study

Design/Methods: Due to a lack of intrinsic quality markers for FMT, CDI treatment success-rate was deemed most relevant. CDI treatment success was defined as either clinical remission or microbiological eradication (on PCR or stool-culture). The success-rate of cFMT was compared to that of our conventionally administered FMT-products, cFMT purchased from the similar center and data from comparable studies. As cFMT offers several practical advantages to conventionally administered FMT, a lower success-rate would be acceptable. We created a database of FMT treatments with our products from 2017 to 2022, based on provisions data and retrospective analyses of patient records.

Results/Findings: Our study included 126 patients receiving 180 FMT treatments for recurring CDI. The similar center's cFMT-products accounted for 29 treatments. The success-rate of our cFMT was lower (65%) than colonoscopy-administered FMT (79%). Both findings are comparable to other studies. Patient age >65 years and increased Charlson Comorbidity Index were associated with treatment failure. Thirteen donors provided donations for our FMT products. Eight male and five female, ages 26-61 years. Donor data from the similar center was unavailable. FMTs from different donors generally had success-rates between 65-80%. A single donor had a success-rate < 50% and 1 donor had a success-rate of 100%. Both were used in < 10 treatments. Our limited data suggest a higher treatment success-rate of gender matched donors (75%) compared to unmatched donors (65%). The high success-rate of aged matched donors (81%) is likely due to confounding. FMT-products were mainly administered within 18 months of production, but products older than 18 months had similar success-rates.

Conclusions: The quality of cFMT produced at our institution, as measured by CDI treatment success-rate was lower than conventionally administered FMT, but was within acceptable and expected levels. Thus, we also demonstrated that the similar Danish center's cFMT production could be replicated externally.

Importance of research: Fecal Microbiota Transplant (FMT) is an emerging therapy and the demand is expected to increase. Our blood and tissue bank manages FMT as a substance of human origin. This study presents a method for quality assurance of FMT products and demonstrates the viability of producing safe and effective capsule based FMT-products at a blood and tissue transplant service, using externally developed production methods from a similar institution.