Can a tiny capsule map the Gut's hidden microbes in IBD?

NCT ID NCT07799506

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
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Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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When the status isn't known

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First seen Sep 02, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

Researchers are testing a visual sampling capsule that collects fluid from different parts of the intestine without surgery. They will use it in 250 people, including those with active or remission Crohn's disease or ulcerative colitis, plus healthy volunteers. By analyzing the microbes and metabolites in these samples, the study aims to identify what triggers disease and what predicts flares or recovery. The capsule's safety and feasibility in IBD patients will also be assessed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Visual sampling capsule endoscopy for intestinal fluid collection
What this could lead to
If successful, this could reveal region-specific gut microbes and metabolites that trigger IBD flares, predict remission, or guide prognosis, potentially leading to better diagnostics and targeted treatments.
What could go wrong
This is an observational study, so it won't test a treatment. The capsule may be less feasible or safe in some IBD patients, and findings may not apply beyond the studied groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants will be selected from healthy volunteers and patients receiving care at the study hospital (Changhai Hospital). The study population will include five groups: healthy controls, patients with active Crohn's disease, patients with Crohn's disease in remission, patients with active ulcerative colitis, and patients with ulcerative colitis in remission.Patients with inflammatory bowel disease (IBD) will be identified through outpatient clinics, inpatient wards, and routine clinical evaluation. Participants will be recruited using a non-probability sampling approach from outpatient clinics, inpatient wards, and healthy volunteer sources at Changhai Hospital.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria General Inclusion Criteria: 1. Male or female, aged 18 years or older and 80 years or younger; 2. Willing and able to complete the study assessments, including repeated capsule endoscopy examinations and daily records of diet, activity, and defecation; 3. Willing to provide fecal (stool), saliva, and intestinal fluid samples and to consent to long-term storage of the provided samples for research purposes; 4. Willing to avoid vigorous physical activity during participation in this clinical trial; 5. Willing to participate in this clinical trial and to sign the informed consent form. Inclusion Criteria for Patients with Ulcerative Colitis (UC): 1. Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months during the screening period (Day -14 to 0), confirmed by endoscopic and histological evidence, with a histopathology report (if no report is available, endoscopy and histological examination may be performed at screening); 2. Diagnosis established by at least one of the following clinically accepted methods: endoscopy (e.g., colonoscopy) showing typical UC manifestations; histopathological examination consistent with UC features; imaging studies (e.g., CTE, MRE) showing typical UC changes; or comprehensive assessment by a digestive specialist based on clinical presentation, laboratory tests (e.g., fecal calprotectin, inflammatory markers), and exclusion of infectious enteropathy. Inclusion Criteria for Patients with Crohn's Disease (CD): 1\. Confirmed diagnosis of Crohn's disease (CD) by at least one of the following clinically accepted methods: endoscopy (e.g., colonoscopy) showing typical CD manifestations; histopathological examination consistent with CD features; imaging studies (e.g., CTE, MRE) showing typical CD changes; or comprehensive assessment by a digestive specialist based on clinical presentation, laboratory tests, and exclusion of infectious enteropathy. Inclusion Criteria for Healthy Subjects: 1. No chronic gastrointestinal symptoms (e.g., abdominal pain, diarrhea, constipation, hematochezia, bloating); 2. No history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, or other chronic gastrointestinal disorders; 3. A normal colonoscopy within the past year, or a negative fecal occult blood test with no related symptoms if colonoscopy has not been performed. If any of the above items is answered "No", the subject cannot enter the study. Exclusion Criteria: 1. Other gastrointestinal diseases, including gastrointestinal cancer, indeterminate colitis, infectious colitis or colitis with a definite etiology, and toxic megacolon (for the UC cohort, Crohn's disease is also excluded; for the CD cohort, ulcerative colitis is also excluded); 2. Known or suspected gastrointestinal obstruction, stricture, diverticulum, fistula, or perforation; 3. Severe cardiac, pulmonary, or renal insufficiency, liver cirrhosis, hepatic insufficiency, or hematologic diseases; 4. Known or suspected malignant tumors, acute severe illness, or other end-stage diseases, or concomitant diseases with an expected survival of less than 12 months; 5. Any active infection caused by bacteria, viruses, fungi, or other pathogens, or recurrent or chronic infection; 6. Receipt of anti-infective treatment (including antibacterial, antifungal, or antiviral agents) within 3 months before enrollment; 7. Other medications (to be specified); 8. Inability to undergo or refusal to undergo any abdominal surgery (capsule retention cannot be surgically managed); 9. Planned magnetic resonance imaging (MRI) before the capsule endoscope is excreted; 10. Dysphagia; 11. Pregnant or lactating women; 12. Poor general condition and inability to tolerate sampling capsule endoscopy; 13. Any form of active substance abuse or dependence (including drug or alcohol abuse), any unstable physical or mental illness, or any chronic condition that the investigator considers may interfere with the conduct of the study; 14. Participation in another clinical trial within three months, or current participation in another clinical trial; 15. Any other factors that the investigator considers unsuitable for enrollment or that may affect the participant's participation in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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