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

Not Applicable

Not yet recruiting

• Conditions: Healthy Volunteers Only

• Registration Number: NCT06735196
• Lead Sponsor: Changhai Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Study Start: 2024-12-30
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The feasibility of sampling capsule endoscopy system in collecting fluids from different intestinal segments in healthy volunteers	two weeks	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.

Secondary Outcome Measures

Name	Time	Method
Standard gastrointestinal preparation procedure	two week	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	two weeks	The total time for sampling intestinal fluids of a SCE.
Sampling volume	two weeks	The overall volume of samples obtained by a SCE during a single examination.
Number of sampling times	two weeks	Times we tried to sample during a single SCE examination.
Safety analysis	from enrollment to the end of follow-up at 30 days	All adverse events occurring during the study

Trial Locations

Locations (1)

First Affiliated Hospital of Naval Medical University (Changhai Hospital); 🇨🇳 Shanghai, Shanghai, China