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

NCT06735196 | Not Yet Recruiting DMC

• 1 other identifier: SCE-I
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers Only

Keywords

sampling capsule endoscopy; gut microorganisms; intestinal fluids; stool; saliva

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Standard gastrointestinal preparation procedure

  two week

• Sampling time

  two weeks

• Sampling volume

  two weeks

• Number of sampling times

  two weeks

• Safety analysis

  from enrollment to the end of follow-up at 30 days

Study Arms (1)

Healthy volunteers

OTHER

After standard gastrointestinal preparation, healthy volunteers swallowed SCEs to collect intestinal fluids in different intestinal areas.

Device: sampling capsule endoscopy

Interventions

sampling capsule endoscopy DEVICE

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.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;
• The researcher believes any other factors are unsuitable for selection or affect the subject's participation in the study.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

First Affiliated Hospital of Naval Medical University (Changhai Hospital)

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (3)

• 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.

  PMID: 22258098 BACKGROUND

• 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.

  PMID: 31344510 BACKGROUND

• 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.

  PMID: 33452177 BACKGROUND

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Zhuan Liao, Doctor

  First Affiliated Hospital of Naval Medical University (Changhai Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen He, Doctor

CONTACT

86+021 31162770; hchenc@126.com

Xi Jiang, Doctor

CONTACT

86+021 31162770; jiangxi_stella@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: December 30, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

CN (1)