Blood and stool tests could revolutionize IBD monitoring
NCT ID NCT07686406
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This observational study is collecting blood, stool, and tissue samples from 6,000 people with inflammatory bowel disease (Crohn's disease or ulcerative colitis), along with their relatives and healthy volunteers. Researchers aim to identify biomarkers that can assess intestinal inflammation, monitor how well routine treatments are working, and predict disease progression. The goal is to develop simple tests that could replace or reduce the need for invasive procedures like colonoscopies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to better ways to monitor Crohn's disease and ulcerative colitis, helping doctors predict flare-ups and tailor treatments to each patient.
- What could go wrong
- This is an observational study, not a treatment trial. It may take years to validate any biomarkers, and the findings might not lead to immediate changes in patient care.
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
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About 6,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
This multicenter prospective observational cohort will enroll approximately 6,000 participants aged 14 years or older. The study population may include participants with inflammatory bowel disease, including Crohn's disease, ulcerative colitis, or IBD-unclassified; unaffected first-degree relatives of participants with inflammatory bowel disease; unrelated healthy controls; and non-IBD disease controls. Clinical information, treatment exposure data, follow-up outcomes, and biospecimens may be collected to support biomarker discovery, validation, multi-omics research, treatment monitoring, and risk stratification. Participants with severe active infection, pregnancy or lactation, severe mental illness, or major confounding systemic inflammatory or autoimmune diseases may be excluded.
- Ages
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14 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
Eligibility Criteria: Inclusion Criteria: 1. General inclusion criteria for all participants: * Age 14 years or older. * Able to provide written informed consent; for minors, consent from a legal guardian and assent from the participant will be obtained according to local ethics requirements. * Willing to provide clinical information and/or biospecimens, which may include blood, stool, intestinal tissue, or other available biological samples. * Able to participate in study-related data and sample collection according to the study protocol. 2. Participants with inflammatory bowel disease: * Diagnosed with inflammatory bowel disease, including Crohn's disease, ulcerative colitis, or IBD-unclassified when applicable, according to accepted national or international diagnostic criteria. * May be newly diagnosed, previously diagnosed, under routine follow-up, or receiving routine clinical treatment. * Clinical data, treatment exposure information, laboratory results, endoscopic findings, histologic findings, imaging findings, biospecimens, and follow-up outcomes may be available or collected. 3. Unaffected first-degree relatives of participants with inflammatory bowel disease: * Biological first-degree relatives of participants with inflammatory bowel disease, including parents, siblings, or offspring. * No prior diagnosis of inflammatory bowel disease at enrollment. * Willing to provide clinical information and/or biospecimens for family-based genetic, environmental, immune, microbiome, and multi-omics analyses. 4. Unrelated healthy controls: * Individuals without a diagnosis of inflammatory bowel disease. * No first-degree biological relationship to enrolled participants with inflammatory bowel disease. * No known active gastrointestinal inflammatory disease at enrollment. 5. Non-IBD disease controls: * Individuals with gastrointestinal symptoms or other non-IBD conditions who undergo clinical evaluation but are not diagnosed with inflammatory bowel disease. * Clinical information and/or biospecimens may be collected as disease controls when appropriate. Exclusion Criteria: * Refusal or inability to provide informed consent or required assent when applicable. * Active severe infection or chronic infectious disease that may substantially affect biomarker interpretation, including active tuberculosis, active hepatitis B or C, HIV infection, or other clinically significant active infection. * Pregnancy or lactation at the time of enrollment. * Severe mental illness, cognitive impairment, or other condition that prevents cooperation with study procedures. * Known primary extraintestinal autoimmune disease or systemic inflammatory disease that is considered the main disease and may substantially confound biomarker interpretation. * Current or recent participation in another interventional clinical trial that may substantially affect the study biomarkers or outcome assessments, as judged by the investigator. * History of malignant tumor or other severe comorbidity that may substantially affect study participation or biomarker interpretation, as judged by the investigator. * Inadequate biospecimen quality, missing key clinical information, or inability to complete essential study assessments for the relevant analysis.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Sixth Affiliated Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510000, China
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The Sixth Affiliated Hospital, Sun Yat-sen University
COMPLETEDGuangzhou, Guangdong, 510655, China
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- A 7,000-person study hunts for hidden clues that predict Crohn's and colitis