Clinical trial NCT06735196: Profiling the Variation of Microbiome Along the Intestinal Tract Based on Sampling Capsule Endoscopy
Official title: Profiling the Variation of Microbiome Along the Intestinal Tract Based on Sampling Capsule Endoscopy: a Feasibility and Safety Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Volunteers Only
Keywords: sampling capsule endoscopy
gut microorganisms
intestinal fluids
stool
saliva
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: The feasibility of sampling capsule endoscopy system in collecting fluids from different intestinal segments in healthy volunteers
timeFrame: two weeks
Secondary outcomes:
measure: Standard gastrointestinal preparation procedure
timeFrame: two week
measure: Sampling time
timeFrame: two weeks
measure: Sampling volume
timeFrame: two weeks
measure: Number of sampling times
timeFrame: two weeks
measure: Safety analysis
timeFrame: from enrollment to the end of follow-up at 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: First Affiliated Hospital of Naval Medical University (Changhai Hospital)
state: Shanghai
Study officials:
affiliation: First Affiliated Hospital of Naval Medical University (Changhai Hospital)
name: Zhuan Liao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.