Predictors of Prognosis in IBD Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSeoul National University Bundang Hospital
About this trial
A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age under 18 years
Patients who were treated with antibiotics or probiotics within the last 3 months
Trial population
Patients who visited Seoul National University Bundang Hospital.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Endoscopic biopsy
Other interventionWhen 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.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Control group1 intervention
Group B: TNF-alpha Inhibitor-naive IBD group1 intervention
Group C: TNF-alpha Inhibitor-treated IBD group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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)
Time frame
Every 2 years. The examination will be suspended when treatment was ended.Sponsors and contacts
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Source ClinicalTrials.gov