NCT06735196

Profiling the Variation of Microbiome Along the Intestinal Tract Based on Sampling Capsule Endoscopy

Profiling the Variation of Microbiome Along the Intestinal Tract Based on Sampling Capsule Endoscopy: a Feasibility and Safety Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Intestinal flora and metabolites are associated with multiple systemic diseases. Current approaches for acquiring information regarding microbiota/metabolites have limitations. We aimed to develop a precise sampling capsule endoscopy (SCE) for the convenient, non-invasive, and accurate acquisition of digestive bioinformation for disease diagnosis and evaluation. The SCE was used for sampling jejunum, ileum, and colon content in healthy volunteers. The GI liquid was then used for microbiome profiling and metabolomics profiling. In this study, we aimed to describe the characteristics and functions of key microflora in the whole intestinal microenvironment of healthy volunteers.

Detailed description

Gut microorganisms involved in human food digestion, immune system regulation, and protection against pathogens are critical in maintaining health. Gut microorganism dysbiosis influences the course of gastrointestinal disease and cardiovascular, neurological, metabolic diseases, and other disorders. Therefore, a deeper understanding of gut microorganisms is indispensable in researching human disorders. However, current sampling methods, including fecal microbial examination, breath hydrogen testing, and invasive endoscopy acquisition, fail to obtain local gut microbiome samples under its chemical environment in natural and unperturbed states. A comfortable, non-invasive, and precise regional intestinal fluid collection device is needed. Recently, novel ingestible devices have collected intestinal fluids from animals' and humans' jejunum, ileum, and colon. Significant differences between bacteria and metabolites in the intestines versus stool have been identified, showing the spatiotemporal structure of the gastrointestinal microbiome and metabolome. Compared with saliva and stool samples, ingestible devices acquired samples in an environment resembling nature, which is more reliable in explaining the association between gut microorganisms dysbiosis and various disorders. However, current ingestible sampling devices still have several limitations. Therefore, a novel sampling capsule endoscopy (SCE) system was developed. This novel SCE can precisely and efficiently acquire intestinal bio information through direct visualization under electric control. This study aims to collect fluids from different segments of the gastrointestinal tract using the SCE system to clarify the differences in the distribution of gut microorganisms in different areas in healthy volunteers and patients with inflammatory bowel disease or colon cancer.

Conditions

• Healthy Volunteers Only

Interventions

Type	Name	Description
DEVICE	sampling capsule endoscopy	Healthy volunteers swallowed SCEs to collect intestinal fluids in different intestinal areas. When SCEs excreted, the fluids inside SCEs would be collected for microbiome and metabolome analysis.

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2024-12-16
• Last updated: 2024-12-16

Locations

1 site across 1 country: China