PII-024 - STABILITY OF THE GUT MICROBIOME FROM HUMAN FECAL SAMPLES COLLECTED BY CONTACTLESS REGIONAL SHIPPING AND ITS APPLICATION IN CLINICAL TRIALS.

N. Ha¹, S. Kim¹, M. Kim², S. Moon²; ¹Jeonbuk National University, ²Jeonbuk National University Medical School.

Background: Importance of conducting contactless clinical trials has been rising in recent years, and all the more so for microbiome studies. When hospital visits are not possible, collecting specimens at home may be an option if sample stability can be assured. This study aims to explore the feasibility of contactless fecal specimen collection by evaluating sample stability of gut microbiome.

Methods: A human-derived material research approved by the Institutional Review Board of Jeonbuk National University Hospital was conducted. Male volunteers aged 19 years or older who provided written informed consent donated fecal samples using the following two methods: (i) Collection at outpatient visit and (ii) Contactless collection at home and shipped to hospital using regional shipping (within-city). Gut microbiome was analyzed by 16S rRNA sequencing method targeting the V3-V4 region and the Amplicon Sequence Variants (ASVs) analysis method. Microbial composition, alpha diversity, and beta diversity were analyzed and visualization was carried out using QIIME2.

Results: A total of sixty fecal samples were collected from ten volunteers. The taxonomic composition at the phylum, family, and genus levels exhibited no significant differences between collection methods. For all tested alpha diversity metrics (Shannon, Pielou evenness, Faith phylogenetic, and observed ASVs), no significant differences were observed between collection methods, as determined by the Kruskal-Wallis test (p < 0.05). Additionally, beta diversity metrics showed no significant variations between collection methods (Bray-Curtis distance: p-value 0.995, Jaccard distance: p-value 0.998, Unweighted Unifrac: p-value 0.999; Weighted Unifrac: p-value 0.984).

Conclusion: This study investigated taxonomic and functional stability of gut microbiome by human fecal sample collection using contactless regional shipping or conventionally visiting the hospital. As a result, no statistically significant differences were observed. It is anticipated that the use of contactless sample collection, as opposed to conventional methods, may enhance patient convenience in clinical trials that require microbiome sample acquisition.