{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T04:58:37Z","timestamp":1787029117517,"version":"build-2736575974"},"reference-count":46,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2024,2,4]],"date-time":"2024-02-04T00:00:00Z","timestamp":1707004800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Direction de la Recherche Clinique et de l\u2019Innovation (DRCI), CHUGA, Grenoble, France","award":["CIFRE 2021-0931"],"award-info":[{"award-number":["CIFRE 2021-0931"]}]},{"name":"Direction de la Recherche Clinique et de l\u2019Innovation (DRCI), CHUGA, Grenoble, France","award":["i-Lab  DOS0172081\/00"],"award-info":[{"award-number":["i-Lab  DOS0172081\/00"]}]},{"name":"Association Nationale Recherche Technologie (ANRT)","award":["CIFRE 2021-0931"],"award-info":[{"award-number":["CIFRE 2021-0931"]}]},{"name":"Association Nationale Recherche Technologie (ANRT)","award":["i-Lab  DOS0172081\/00"],"award-info":[{"award-number":["i-Lab  DOS0172081\/00"]}]},{"name":"Pelican Health, Grenoble, France","award":["CIFRE 2021-0931"],"award-info":[{"award-number":["CIFRE 2021-0931"]}]},{"name":"Pelican Health, Grenoble, France","award":["i-Lab  DOS0172081\/00"],"award-info":[{"award-number":["i-Lab  DOS0172081\/00"]}]},{"DOI":"10.13039\/100016308","name":"BPIFrance","doi-asserted-by":"publisher","award":["CIFRE 2021-0931"],"award-info":[{"award-number":["CIFRE 2021-0931"]}],"id":[{"id":"10.13039\/100016308","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016308","name":"BPIFrance","doi-asserted-by":"publisher","award":["i-Lab  DOS0172081\/00"],"award-info":[{"award-number":["i-Lab  DOS0172081\/00"]}],"id":[{"id":"10.13039\/100016308","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["MPs"],"abstract":"<jats:p>The connection between imbalances in the human gut microbiota, known as dysbiosis, and various diseases has been well established. Current techniques for sampling the small intestine are both invasive for patients and costly for healthcare facilities. Most studies on human gut microbiome are conducted using faecal samples, which do not accurately represent the microbiome in the upper intestinal tract. A pilot clinical investigation, registered as NCT05477069 and sponsored by the Grenoble Alpes University Hospital, is currently underway to evaluate a novel ingestible medical device (MD) designed for collecting small intestinal liquids by Pelican Health. This study is interventional and monocentric, involving 15 healthy volunteers. The primary objective of the study is to establish the safety and the performance of the MD when used on healthy volunteers. Secondary objectives include assessing the device\u2019s performance and demonstrating the difference between the retrieved sample from the MD and the corresponding faecal sample. Multi-omics analysis will be performed, including metagenomics, metabolomics, and culturomics. We anticipate that the MD will prove to be safe without any reported adverse effects, and we collected samples suitable for the proposed omics analyses in order to demonstrate the functionality of the MD and the clinical potential of the intestinal content.<\/jats:p>","DOI":"10.3390\/mps7010015","type":"journal-article","created":{"date-parts":[[2024,2,5]],"date-time":"2024-02-05T03:28:29Z","timestamp":1707103709000},"page":"15","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Pilot Study: Safety and Performance Validation of an Ingestible Medical Device for Collecting Small Intestinal Liquid in Healthy Volunteers"],"prefix":"10.3390","volume":"7","author":[{"given":"Alexandre","family":"Tronel","sequence":"first","affiliation":[{"name":"Pelican Health, 107 rue Aristide Briand, 38600 Fontaine, France"},{"name":"University Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, 38000 Grenoble, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6963-5416","authenticated-orcid":false,"given":"Anne-Sophie","family":"Silvent","sequence":"additional","affiliation":[{"name":"University Grenoble Alpes, Inserm, CHU Grenoble Alpes, CIC, 38000 Grenoble, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Buelow","sequence":"additional","affiliation":[{"name":"University Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, 38000 Grenoble, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2424-8046","authenticated-orcid":false,"given":"Joris","family":"Giai","sequence":"additional","affiliation":[{"name":"University Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, 38000 Grenoble, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0910-2209","authenticated-orcid":false,"given":"Corentin","family":"Leroy","sequence":"additional","affiliation":[{"name":"University Grenoble Alpes, Inserm, CHU Grenoble Alpes, CIC, 38000 Grenoble, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marion","family":"Proust","sequence":"additional","affiliation":[{"name":"University Grenoble Alpes, Inserm, CHU Grenoble Alpes, CIC, 38000 Grenoble, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5913-2372","authenticated-orcid":false,"given":"Donald","family":"Martin","sequence":"additional","affiliation":[{"name":"University Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, 38000 Grenoble, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4905-3854","authenticated-orcid":false,"given":"Audrey","family":"Le Gouellec","sequence":"additional","affiliation":[{"name":"University Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, 38000 Grenoble, France"},{"name":"Service de Biochimie Biologie Mol\u00e9culaire Toxicologie Environnementale, UM Biochimie des Enzymes et des Prot\u00e9ines, Institut de Biologie et Pathologie, CHU Grenoble-Alpes, 38000 Grenoble, France"},{"name":"Plateforme de M\u00e9tabolomique GEMELI-GExiM, Institut de Biologie et Pathologie, CHU Grenoble-Alpes, 38000 Grenoble, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Soranzo","sequence":"additional","affiliation":[{"name":"Pelican Health, 107 rue Aristide Briand, 38600 Fontaine, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Mathieu","sequence":"additional","affiliation":[{"name":"Department of Hepato-Gastroenterology and Digestive Oncology, Grenoble Alpes University Hospital, 38000 Grenoble, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,2,4]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Berg, G., Rybakova, D., Fischer, D., Cernava, T., Verg\u00e8s, M.-C.C., Charles, T., Chen, X., Cocolin, L., Eversole, K., and Corral, G.H. 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