Progression of Damage in Ulcerative Colitis

Not Applicable

• Conditions: Ulcerative Colitis
• Interventions: Diagnostic Test: Magnetic Resonance Imaging

• Registration Number: NCT03955328
• Lead Sponsor: David Garcia Cinca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-15
• Last Update Submitted: 2019-05-15
• Study First Posted: 2019-05-20
• Last Update Posted: 2019-05-20
• Study Start: 2019-06-15
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetic Resonance Imaging	Magnetic Resonance Imaging	A magnetic resonance imaging is perform to detect permanent anatomical damage.

Primary Outcome Measures

Name	Time	Method
Relationship of structural changes in colon morphology and functional changes assessed by MRI with disease duration in UC patients in clinical remission	Baseline	Explorative structural changes

Secondary Outcome Measures

Name	Time	Method
Patient reported outcomes on EQ-5D-5L questionnaire	Baseline	EQ-5D-5L questionnaire a standardized instrument for measuring generic health status, score ranges from -0.224 to 1.
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 with the time since the disease diagnosis	Baseline
Patient reported outcomes on IBDQ-32 questionnaire	Baseline	Inflammatory bowel diseases health-related quality of life index which is a questionnaire of 32 items, score ranges from 32 to 224.
Patient reported outcomes on Work Productivity and Activity questionnaire	Baseline	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)
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 related to anorectal function using Cleveland Clinic Incontinence Score	Baseline	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.

Trial Locations

Locations (4)

Hospital Galdakao; 🇪🇸 Galdakao, Bizkaia, Spain

Hospital Reina Sofía; 🇪🇸 Córdoba, Cordoba, Spain

Hospital Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain