Pilot Study: Safety and Performance Validation of an Ingestible Medical Device for Collecting Small Intestinal Liquid in Healthy Volunteers

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 conduct...

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Bibliographic Details
Published in:Methods and protocols Vol. 7; no. 1; p. 15
Main Authors: Tronel, Alexandre, Silvent, Anne-Sophie, Buelow, Elena, Giai, Joris, Leroy, Corentin, Proust, Marion, Martin, Donald, Le Gouellec, Audrey, Soranzo, Thomas, Mathieu, Nicolas
Format: Journal Article
Language:English
Published: Switzerland MDPI AG 01.02.2024
MDPI
Subjects:
Biomarkers
Biotechnology
Digestive system
Disease prevention
Dysbacteriosis
Endoscopy
Feces
Gastrointestinal tract
ingestible
Intestinal microflora
Life Sciences
medical device
Medical equipment
Medical technology
Metabolism
Metabolites
Metabolomics
Metagenomics
microbiome
Microbiomes
Microbiota
Microbiota (Symbiotic organisms)
Microorganisms
multi-omics
Ostomy
Physiological apparatus
Physiology
pilot study
Small intestine
Volunteers
France
ingestible
heathy volunteers
pilot study
multi-omics
small intestine
medical device
microbiome
ISSN:2409-9279, 2409-9279
Online Access:Get full text
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Summary: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’s 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.
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ISSN:2409-9279
2409-9279
DOI:10.3390/mps7010015