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NCT06735196

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

Sponsor: Changhai Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-12-30

Completion Date

2026-03-31

Last Updated

2024-12-16

Healthy Volunteers

Conditions

Healthy Volunteers Only

Interventions

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.

Inclusion Criteria: 1. Male or female, age ≥18 years and ≤80 years; 2. American Society of Anesthesiologists (ASA) physical health risk level 1; 3. Good overall health, no clinically significant medical history; 4. No clinically significant signs were found in the physical examination; 5. 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; 6. 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. 7. Agree to avoid strenuous activities during the participation in this clinical trial; 8. Agree to participate in this clinical trial and sign the informed consent form. Exclusion Criteria: 1. Patients with digestive tract diseases such as cancer, inflammatory bowel disease, achalasia, esophageal diverticulum, etc.; 2. Patients who have participated in other clinical trials within three months or are currently participating in other clinical trials; 3. Patients currently use medication for other diseases or plan to use medication for treatment; 4. Patients who have used antibiotics within three months; 5. Patients with known or suspected gastrointestinal obstruction, stenosis, diverticulum, and fistula; 6. Patients with swallowing disorders; 7. Pregnant or lactating women or women who plan to become pregnant within 30 days of the visit period; 8. 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); 9. Patients with any form of active substance abuse or dependence (including drug or alcohol abuse), any unstable physical or mental illness, any malignant lesions in any location or system, or any chronic disease that the researcher believes may interfere with the study; 10. The researcher believes any other factors are unsuitable for selection or affect the subject's participation in the study.

Locations (1)

First Affiliated Hospital of Naval Medical University (Changhai Hospital)

Shanghai, Shanghai Municipality, China