Healthy Volunteers OnlyNCT06735196
Profiling the Variation of Microbiome Along the Intestinal Tract Based on Sampling Capsule Endoscopy
A study testing sampling capsule endoscopy in people with Healthy Volunteers Only, run by Changhai Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Healthy Volunteers Only
- What is being tested?
- sampling capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Naval Medical University (Changhai Hospital)
Shanghai, Shanghai Municipality, 200433
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers Only
- Being tested
- sampling capsule endoscopy
- Keywords
- sampling capsule endoscopy, gut microorganisms, intestinal fluids, stool, saliva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sampling capsule endoscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | After standard gastrointestinal preparation, healthy volunteers swallowed SCEs to collect intestinal fluids in different intestinal areas. Receives: Device: sampling capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two weeks
Secondary outcomes (5)
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) .
Measured: two week
Sampling time
The total time for sampling intestinal fluids of a SCE.
Measured: two weeks
Sampling volume
The overall volume of samples obtained by a SCE during a single examination.
Measured: two weeks
Number of sampling times
Times we tried to sample during a single SCE examination.
Measured: two weeks
Safety analysis
All adverse events occurring during the study
Measured: from enrollment to the end of follow-up at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start30 Dec 2024
- Primary completion31 Dec 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers OnlyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, Doctor, Principal investigator, First Affiliated Hospital of Naval Medical University (Changhai Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735196
- Sponsor's protocol ID
- SCE-I
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 22258098Kastl 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.
PubMed 31344510Ding 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.
PubMed 33452177
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling the Variation of Microbiome Along the Intestinal Tract Based on Sampling Capsule Endoscopy: a Feasibility and Safety Study
- ClinicalTrials.gov ID
- NCT06735196
- Acronym / sponsor ID
- SCE-I
- Conditions
- Healthy Volunteers Only
- Keywords
- sampling capsule endoscopy, gut microorganisms, intestinal fluids, stool, saliva
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Device: sampling capsule endoscopyAfter standard gastrointestinal preparation, healthy volunteers swallowed SCEs to collect intestinal fluids in different intestinal areas. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sampling capsule endoscopyHealthy 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. | Device | Healthy volunteers |
Primary outcome
The feasibility of sampling capsule endoscopy system in collecting fluids from different intestinal segments in healthy volunteers
Time frame: 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.
5 secondary outcomes
Standard gastrointestinal preparation procedure
Time frame: two week
Sampling time
Time frame: two weeks
Sampling volume
Time frame: two weeks
Number of sampling times
Time frame: two weeks
Safety analysis
Time frame: from enrollment to the end of follow-up at 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 22258098Zoetendal 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.
- Background: PubMed 31344510Kastl 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.
- Background: PubMed 33452177Ding 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhuan Liao, Doctor principal investigator
First Affiliated Hospital of Naval Medical University (Changhai Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sampling capsule endoscopy in people with Healthy Volunteers Only, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of sampling capsule endoscopy system in collecting fluids from different intestinal segments in healthy volunteers (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06735196, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.