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

Launched by CHANGHAI HOSPITAL · Dec 11, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on studying the tiny organisms, known as the microbiome, that live in our intestines and how they might be linked to various health conditions. The researchers are using a special tool called a sampling capsule endoscopy (SCE) that can safely and easily collect samples from different parts of the digestive system in healthy volunteers. By analyzing these samples, they hope to better understand the important roles that these microorganisms play in our overall health.

To participate in this trial, you need to be an adult between 18 and 80 years old, in good health, and not have any serious digestive diseases. Both men and women can join, but women must be willing to take precautions to prevent pregnancy during the study. Participants will provide various samples, including blood and stool, and will be asked to take it easy and avoid strenuous activities during the trial. It’s important to note that those with certain health conditions or who are currently taking medications may not be eligible. Overall, this study aims to gather valuable information that could help diagnose and treat diseases related to the microbiome in the future.

Gender

ALL

Eligibility criteria

• 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.