An interventional study of sampling capsule endoscopy in Healthy Volunteers Only, sponsored by Changhai Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Other
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.
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.
Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
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After standard gastrointestinal preparation, healthy volunteers swallowed SCEs to collect intestinal fluids in different intestinal areas.
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.
The feasibility of sampling capsule endoscopy system in collecting fluids from different intestinal segments in healthy volunteers
The total successful rate of SCE in sampling fluids in intestinal segments. A successful sampling procedure conducted by SCE was defined when the following conditions were met simultaneously: 1) accurately recognization of target intestinal areas. 2) the intestinal liquid can be successfully collected in the sampling chamber.
Time frame: two weeks
Standard gastrointestinal preparation procedure
To select the best standard gastrointestinal preparation procedure which makes the visualization score under SCE graded as the best (on a scale of 1 to 5; 1, the worst; 5, the best) .
Time frame: two week
Sampling time
The total time for sampling intestinal fluids of a SCE.
Time frame: two weeks
Sampling volume
The overall volume of samples obtained by a SCE during a single examination.
Time frame: two weeks
Number of sampling times
Times we tried to sample during a single SCE examination.
Time frame: two weeks
Safety analysis
All adverse events occurring during the study
Time frame: from enrollment to the end of follow-up at 30 days
Plan to share: Undecided
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Changhai Hospital