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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers Only
• Intervention / Treatment: Device: sampling capsule endoscopy

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen He, Doctor; Phone Number: 86+021 31162770; Email: hchenc@126.com
• Study Contact Backup: Name: Xi Jiang, Doctor; Phone Number: 86+021 31162770; Email: jiangxi_stella@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • First Affiliated Hospital of Naval Medical University (Changhai Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy volunteers; After standard gastrointestinal preparation, healthy volunteers swallowed SCEs to collect intestinal fluids in different intestinal areas.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	two weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Zhuan Liao, Doctor, First Affiliated Hospital of Naval Medical University (Changhai Hospital)

Publications and helpful links

General Publications

• Zoetendal EG, Raes J, van den Bogert B, Arumugam M, Booijink CC, Troost FJ, Bork P, Wels M, de Vos WM, Kleerebezem M. The human small intestinal microbiota is driven by rapid uptake and conversion of simple carbohydrates. ISME J. 2012 Jul;6(7):1415-26. doi: 10.1038/ismej.2011.212. Epub 2012 Jan 19.
• Kastl AJ Jr, Terry NA, Wu GD, Albenberg LG. The Structure and Function of the Human Small Intestinal Microbiota: Current Understanding and Future Directions. Cell Mol Gastroenterol Hepatol. 2020;9(1):33-45. doi: 10.1016/j.jcmgh.2019.07.006. Epub 2019 Jul 22.
• Ding Z, Wang W, Zhang K, Ming F, Yangdai T, Xu T, Shi H, Bao Y, Yao H, Peng H, Han C, Jiang W, Liu J, Hou X, Lin R. Novel scheme for non-invasive gut bioinformation acquisition with a magnetically controlled sampling capsule endoscope. Gut. 2021 Dec;70(12):2297-2306. doi: 10.1136/gutjnl-2020-322465. Epub 2021 Jan 15.

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: saliva; stool; gut microorganisms; sampling capsule endoscopy; intestinal fluids
• Other Study ID Numbers: SCE-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No