Inflammatory Bowel DiseasesNCT05653011
Predictors of Prognosis in IBD Patients
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Endoscopic biopsy
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2013to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Patients who visited Seoul National University Bundang Hospital.
Who may be able to join
- control group: Patients who do not have colitis, cancer, and advanced polyp (the number of polyps ≥ 3, the size of polyps ≥ 1cm, high-grade adenoma, villous adenoma)
- TNF-α inhibitor-naive IBD group: IBD patients who do not have a history of TNF-α inhibitor treatment
- TNF-α inhibitor-treated IBD group: IBD patients who are treated with TNF-α inhibitor
Who cannot join
- Age under 18 years
- Patients who were treated with antibiotics or probiotics within the last 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Nayoung Kim, M.D.,Ph.D.
About this study
Official title: Predictors of Response After Induction Therapy With TNF-alpha Inhibitor in Inflammatory Bowel Disease, Comparison to Normal
A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease
Read the detailed description
Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory disease composed of two types: Crohn's disease (CD) and ulcerative colitis (UC). It is difficult to cure the IBD completely and patients with clinical or endoscopic remission can worsen again. Therefore, predicting the prognosis of patients with IBD is still challenging.
Endoscopic biopsied samples and blood samples from IBD patients and non-IBD controls have been collected and the expression levels of multiple markers which are associated with disease activity and severity will be assessed. The correlation between expression levels of multiple markers and prognosis will be evaluated.
- Being tested
- Endoscopic biopsy
- Keywords
- inflammatory bowel disease, ulcerative colitis, crohn's disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic biopsyOther
When patients have colonoscopy or sigmoidoscopy for evaluation of their disease course, biopsied samples are collected.
In the IBD group, samples are obtained at endoscopically active and/or inactive lesions. In the control group, samples are obtained at endoscopically normal lesions.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients who are not diagnosed with inflammatory bowel disease and have colitis. Receives: Other: Endoscopic biopsy | |
| TNF-alpha Inhibitor-naive IBD group | Patients who are diagnosed with inflammatory bowel disease but do not have a history of TNF-a inhibitor treatment. Receives: Other: Endoscopic biopsy | |
| TNF-alpha Inhibitor-treated IBD group | Patients who are diagnosed with inflammatory bowel disease and have a history of TNF-a inhibitor treatment. Receives: Other: Endoscopic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The expression level of multiple markers associated with IBD activity or prognosis
The expression level of multiple markers was evaluated through RT-qPCR using endoscopically biopsied samples or blood samples. Markers include TGF-b, SLUG, SNAIL, E-cadherin, vimentin, OLFM4, LGR5, a-SMA, FSP1, IL-17A, IL-23, TGF-b, IL-6, IFN-r, IL-1b, FOXP3, PD-1, CD68, PAD4, COL3A1, TIMP3, LOX, ACTA2, ITGB6, CAV-1 etc.
Measured: baseline (at the time of enrollment)
Secondary outcomes (1)
The change of expression level of multiple markers associated with IBD activity or prognosis
The change of expression level of multiple markers was evaluated through RT-qPCR using endoscopically biopsied samples or blood samples. Markers include TGF-b, SLUG, SNAIL, E-cadherin, vimentin, OLFM4, LGR5, a-SMA, FSP1, IL-17A, IL-23, TGF-b, IL-6, IFN-r, IL-1b, FOXP3, PD-1, CD68, PAD4, COL3A1, TIMP3, LOX, ACTA2, ITGB6, CAV-1 etc. (compared to results 2 year ago)
Measured: Every 2 years. The examination will be suspended when treatment was ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start11 Mar 2013
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
- Investigators
- Nayoung Kim, M.D., Ph.D, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653011
- Sponsor's protocol ID
- B-1305-201-001
- Status last verified
- Apr 2026
- First submitted
- 25 Oct 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jun YK, Kim N, Yoon H, Park JH, Kim HK, Choi Y, Lee JA, Shin CM, Park YS, Lee DH. Molecular Activity of Inflammation and Epithelial-Mesenchymal Transition in the Microenvironment of Ulcerative Colitis. Gut Liver. 2024 Nov 15;18(6):1037-1047. doi: 10.5009/gnl230283. Epub 2024 Feb 22.
PubMed 38384179
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Response After Induction Therapy With TNF-alpha Inhibitor in Inflammatory Bowel Disease, Comparison to Normal
- ClinicalTrials.gov ID
- NCT05653011
- Acronym / sponsor ID
- B-1305-201-001
- Keywords
- inflammatory bowel disease, ulcerative colitis, crohn's disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 11 Mar 2013 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Dec 2022 (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.
A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease
Detailed description
Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory disease composed of two types: Crohn's disease (CD) and ulcerative colitis (UC). It is difficult to cure the IBD completely and patients with clinical or endoscopic remission can worsen again. Therefore, predicting the prognosis of patients with IBD is still challenging.
Endoscopic biopsied samples and blood samples from IBD patients and non-IBD controls have been collected and the expression levels of multiple markers which are associated with disease activity and severity will be assessed. The correlation between expression levels of multiple markers and prognosis will be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Endoscopic biopsyPatients who are not diagnosed with inflammatory bowel disease and have colitis. |
| TNF-alpha Inhibitor-naive IBD group | – | Other: Endoscopic biopsyPatients who are diagnosed with inflammatory bowel disease but do not have a history of TNF-a inhibitor treatment. |
| TNF-alpha Inhibitor-treated IBD group | – | Other: Endoscopic biopsyPatients who are diagnosed with inflammatory bowel disease and have a history of TNF-a inhibitor treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who visited Seoul National University Bundang Hospital.
Key inclusion criteria (3 listed)
- control group: Patients who do not have colitis, cancer, and advanced polyp (the number of polyps ≥ 3, the size of polyps ≥ 1cm, high-grade adenoma, villous adenoma)
- TNF-α inhibitor-naive IBD group: IBD patients who do not have a history of TNF-α inhibitor treatment
- TNF-α inhibitor-treated IBD group: IBD patients who are treated with TNF-α inhibitor
Key exclusion criteria (2 listed)
- Age under 18 years
- Patients who were treated with antibiotics or probiotics within the last 3 months
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 |
|---|---|---|
| Endoscopic biopsyWhen patients have colonoscopy or sigmoidoscopy for evaluation of their disease course, biopsied samples are collected. In the IBD group, samples are obtained at endoscopically active and/or inactive lesions. In the control group, samples are obtained at endoscopically normal lesions. | Other | Control group, TNF-alpha Inhibitor-naive IBD group, TNF-alpha Inhibitor-treated IBD group |
Primary outcome
The expression level of multiple markers associated with IBD activity or prognosis
Time frame: baseline (at the time of enrollment)
The expression level of multiple markers was evaluated through RT-qPCR using endoscopically biopsied samples or blood samples. Markers include TGF-b, SLUG, SNAIL, E-cadherin, vimentin, OLFM4, LGR5, a-SMA, FSP1, IL-17A, IL-23, TGF-b, IL-6, IFN-r, IL-1b, FOXP3, PD-1, CD68, PAD4, COL3A1, TIMP3, LOX, ACTA2, ITGB6, CAV-1 etc.
1 secondary outcome
The change of expression level of multiple markers associated with IBD activity or prognosis
Time frame: Every 2 years. The examination will be suspended when treatment was ended.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 38384179Jun YK, Kim N, Yoon H, Park JH, Kim HK, Choi Y, Lee JA, Shin CM, Park YS, Lee DH. Molecular Activity of Inflammation and Epithelial-Mesenchymal Transition in the Microenvironment of Ulcerative Colitis. Gut Liver. 2024 Nov 15;18(6):1037-1047. doi: 10.5009/gnl230283. Epub 2024 Feb 22.
- Individual participant dataSharing planned: No
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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.
Nayoung Kim, M.D., Ph.D study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Apr 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu kyung Jun, M.D., Ph.D (+ 82-31-787-7845, juk0220@nate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The expression level of multiple markers associated with IBD activity or prognosis (time frame: baseline (at the time of enrollment)). 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 NCT05653011, which also lists 1 linked publication.
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 24 Apr 2026.