Progression of Damage in Ulcerative Colitis

Study Overview
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Brief Summary
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The hypothesis of the study is that in ulcerative colitis repeated flares of inflammatory activity, as well as mechanisms involved in resolution of the inflammatory response, may contribute to accumulation of damage in the colon leading to functional disturbances and symptoms that affect patient's functioning. The primary objective is to determine whether ulcerative colitis induces permanent anatomical damage, by means of magnetic resonance imaging.

Official Title
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Progression of Damage in Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Diagnostic Test: Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes aged >18 years and <72 years. Ulcerative colitis diagnosed according to European Crohn's and Colitis Organization guidelines . Ulcerative colitis in endoscopic remission as demonstrated by a recto-sigmoidoscopy/colonoscopy (defined as: Mayo Endoscopic Score 0-1; Ulcerative Colitis Endoscopic Index of Severity : bleeding 0, vascular 0-1, erosion/ulcers 0). Normal C-reactive protein according local laboratory values. Informed consent for participation. Understands the language of the provided patient questionnaires. Exclusion Criteria: Pregnant women (or pregnancy suspected). Previous colonic surgery. Patients receiving corticosteroids or antidiarrheal medications. Patients with suspected or confirmed active gastrointestinal infection. Patients with a diagnosis of other gastrointestinal disorders that may result in symptoms including, but not limited to, celiac disease, intolerance to disaccharides and pancreatic disorders. Diabetes. Thyroid disorders. Liver disease. Any other systemic disease that, according to the investigator's criteria, might influence the variables investigated. Patients with history of colonic dysplasia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic Resonance Imaging<br>A magnetic resonance imaging is perform to detect permanent anatomical damage. | Diagnostic Test: Magnetic Resonance Imaging<br>* A magnetic resonance imaging is perform to detect permanent anatomical damage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of structural changes in colon morphology and functional changes assessed by MRI with disease duration in UC patients in clinical remission | Explorative structural changes | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes on IBDQ-32 questionnaire | Inflammatory bowel diseases health-related quality of life index which is a questionnaire of 32 items, score ranges from 32 to 224. | Baseline | 
| Patient reported outcomes on EQ-5D-5L questionnaire | EQ-5D-5L questionnaire a standardized instrument for measuring generic health status, score ranges from -0.224 to 1. | Baseline | 
| Patient reported outcomes on Work Productivity and Activity questionnaire | Work Productivity and Activity Impairment questionnaire is a well validated instrument to measure impairments in work and activities. Consists in 6 questions: question1: yes/no, questions 2 to 4: number of hours (count data), question 5: global rating scale, 0-10 (0 = health problems had no effect on my work, 10 = health problems completely prevented me from working), question 6: global rating scale, 0-10 (0 = health problems had no effect on my daily activities, 10 = health problems completely prevented me from doing my daily activities) | Baseline | 
| Patient reported outcomes on Disability Index questionnaire |  | Baseline | 
| To identify disease characteristics associated with permanent/accumulated damage disease severity with number of f the hospital admissions |  | Baseline | 
| To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of corticoesteroids |  | Baseline | 
| To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of immunosuppressants |  | Baseline | 
| To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of biologics drugs |  | Baseline | 
| To identify disease characteristics associated with permanent/accumulated damage with the disease extension at diagnosis and maximal extension of the disease at any time proctitis |  | Baseline | 
| To identify disease characteristics associated with permanent/accumulated damage with the disease extension at diagnosis and maximal extension of the disease at any time left colitis |  | Baseline | 
| To identify disease characteristics associated with permanent/accumulated damage with the disease extension at diagnosis and maximal extension of the disease at any time extensive colitis |  | Baseline | 
| To identify disease characteristics associated with permanent/accumulated damage with the time since the disease diagnosis |  | Baseline | 
| To identify disease characteristics associated with permanent/accumulated damage related to anorectal function using Cleveland Clinic Incontinence Score | Cleveland Clinic Incontinence Score is a questionnaire that reports the consistency and frequency of depositions is a 5 questions questionnaires with 7 possible answers each question. | Baseline |