Profiling the Variation of Microbiome Along the Intestinal Tract Based on Sampling Capsule Endoscopy (NCT06735196) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Profiling the Variation of Microbiome Along the Intestinal Tract Based on Sampling Capsule Endoscopy
China40 participantsStarted 2024-12-30
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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;
✓. For women of fertility, the urine pregnancy test was negative within 7 days after the screening visit, and they were willing to take contraceptive measures throughout the study;
✓. Willing to provide blood samples, stool samples, urine samples, saliva samples, and intestinal fluid samples, and agree that the samples provided will be stored for a long time and used for research purposes.
✓. Agree to avoid strenuous activities during the participation in this clinical trial;
✓. Agree to participate in this clinical trial and sign the informed consent form.
Exclusion criteria
✕
What they're measuring
1
The feasibility of sampling capsule endoscopy system in collecting fluids from different intestinal segments in healthy volunteers
. 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;
✕. Patients with known or suspected gastrointestinal obstruction, stenosis, diverticulum, and fistula;
✕. Patients with swallowing disorders;
✕. Pregnant or lactating women or women who plan to become pregnant within 30 days of the visit period;
✕. Patients who are not suitable for surgery or refuse to undergo any abdominal surgery (once the capsule is retained, it cannot be removed by surgery);