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.
Male or female, age ≥18 years and ≤80 years;
American Society of Anesthesiologists (ASA) physical health risk level 1;
Good overall health, no clinically significant medical history;
No clinically significant signs were found in the physical examination;
Patients with digestive tract diseases such as cancer, inflammatory bowel disease, achalasia, esophageal diverticulum, etc.;
Patients who have participated in other clinical trials within three months or are currently participating in other clinical trials;
Patients currently use medication for other diseases or plan to use medication for treatment;
Patients who have used antibiotics within three months;
Single group
sampling capsule endoscopy
DeviceHealthy 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.
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) .
Sampling time
The total time for sampling intestinal fluids of a SCE.
Sampling volume
The overall volume of samples obtained by a SCE during a single examination.
Number of sampling times
Times we tried to sample during a single SCE examination.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
