Searching for blood, stool and tissue markers in Crohn's disease and ulcerative colitis
Collects samples from people with inflammatory bowel disease to find markers of disease activity.
Key facts
- Who runs it
- Sixth Affiliated Hospital, Sun Yat-sen University
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- IBD Biomarker Discovery and Validation Platform
- Status
- Recruiting
- People taking part
- 6,000 people, planned
- Started
- 1 Jan 2022
- Expected to end
- 31 Dec 2028
- Type of study
- Observational, 4 groups
- Record updated
- 7 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with Crohn's disease or ulcerative colitis. It also takes healthy people, unaffected close relatives and people with other bowel problems.
- Age
- 14 years or older.
- Sex
- All sexes can join.
- Disease stage
- People with Crohn's disease, ulcerative colitis or IBD-unclassified. They can be newly diagnosed or already treated.
- Earlier treatment
- No treatment is required. Treatment is chosen by the treating doctors as part of routine care.
Main reasons for not taking part
- Active severe infection, such as active tuberculosis, hepatitis B or C, or HIV infection
- Pregnancy or breastfeeding at enrolment
- Severe mental illness or a condition that prevents taking part in the study
- History of cancer or another severe illness that may affect the results
- Taking part in another interventional trial that may affect the results
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
- 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
- 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
- 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
- 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
Who cannot take part
- 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
- 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
- History of malignant tumor or other severe comorbidity that may substantially affect study participation or biomarker interpretation, as judged by the investigator
- Refusal or inability to provide informed consent or required assent when applicable
- Pregnancy or lactation at the time of enrollment
- Current or recent participation in another interventional clinical trial that may substantially affect the study biomarkers or outcome assessments, as judged by the investigator
- Inadequate biospecimen quality, missing key clinical information, or inability to complete essential study assessments for the relevant analysis
Other criteria
- Eligibility Criteria:
Where in China
- The Sixth Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Wei Wang, MD&PhDTaking people
About the trial
What the trial wants to find out
The goal of this observational study is to establish a multicenter prospective clinical and biospecimen platform for biomarker discovery and validation in inflammatory bowel disease, including Crohn's disease and ulcerative colitis.
Read full original descriptionShow less
Researchers want to learn whether candidate biomarkers or combined biomarker models can help assess intestinal inflammation, monitor response to routine clinical treatment, predict treatment outcomes, and identify participants who may be at higher risk of disease progression.
The study may enroll participants with inflammatory bowel disease, unaffected first-degree relatives of participants with inflammatory bowel disease, unrelated healthy controls, and non-IBD disease controls when appropriate. Clinical information and biological samples, including blood, stool, and intestinal tissue, may be collected. Biomarkers measured in blood, stool, intestinal tissue, genetic data, immune profiles, microbiome data, and other multi-omics data may be evaluated.
The main questions this study aims to answer are:
Can candidate biomarkers or combined biomarker models identify endoscopic disease activity when compared with endoscopic assessment?
Can these biomarkers monitor or predict clinical response, clinical remission, endoscopic response, endoscopic remission, imaging response, or biomarker response during routine clinical care?
Can these biomarkers help predict treatment failure, disease progression, hospitalization, surgery, treatment escalation, or complex Crohn's disease phenotypes?
Participants will not be assigned to any treatment by the study. All treatments and clinical management decisions will be chosen by treating physicians as part of routine medical care.
The 4 groups in the trial
- Participants With Inflammatory Bowel Disease
Participants diagnosed with inflammatory bowel disease, including Crohn's disease, ulcerative colitis, or IBD-unclassified when applicable. Clinical data, treatment exposure information, endoscopic and histologic assessments, laboratory results, imaging findings, biospecimens, and follow-up outcomes may be collected.
- Unaffected First-Degree Relatives of Participants With IBD
Biological first-degree relatives of participants with inflammatory bowel disease, including parents, siblings, or offspring, who have not been diagnosed with inflammatory bowel disease. Clinical information and biospecimens may be collected to support family-based analyses of genetic susceptibility, shared environmental exposure, immune profiles, microbiome features, and multi-omics biomarkers.
- Unrelated Healthy Controls
Healthy control participants without inflammatory bowel disease and without a first-degree biological relationship to enrolled participants with inflammatory bowel disease. Clinical information and biospecimens may be collected as reference controls.
- Non-IBD Disease Controls
Participants with gastrointestinal symptoms or other non-IBD conditions who undergo clinical evaluation but are not diagnosed with inflammatory bowel disease. Clinical information and biospecimens may be collected as disease controls when appropriate.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Biomarker Discovery, Validation, and Multi-Omics Profiling for Disease Activity Assessment, Treatment Monitoring, and Risk Stratification in Inflammatory Bowel Disease: A Multicenter Prospective Biospecimen-Based Observational Cohort Study
- Plain-language title
- Searching for blood, stool and tissue markers in Crohn's disease and ulcerative colitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 7 July 2026