Clinical trial NCT03955328: Progression of Damage in Ulcerative Colitis
Official title: Progression of Damage in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Relationship of structural changes in colon morphology and functional changes assessed by MRI with disease duration in UC patients in clinical remission
timeFrame: Baseline
Secondary outcomes:
measure: Patient reported outcomes on IBDQ-32 questionnaire
timeFrame: Baseline
measure: Patient reported outcomes on EQ-5D-5L questionnaire
timeFrame: Baseline
measure: Patient reported outcomes on Work Productivity and Activity questionnaire
timeFrame: Baseline
measure: Patient reported outcomes on Disability Index questionnaire
timeFrame: Baseline
measure: To identify disease characteristics associated with permanent/accumulated damage disease severity with number of f the hospital admissions
timeFrame: Baseline
measure: To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of corticoesteroids
timeFrame: Baseline
measure: To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of immunosuppressants
timeFrame: Baseline
measure: To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of biologics drugs
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: To identify disease characteristics associated with permanent/accumulated damage with the time since the disease diagnosis
timeFrame: Baseline
measure: To identify disease characteristics associated with permanent/accumulated damage related to anorectal function using Cleveland Clinic Incontinence Score
timeFrame: Baseline
Other outcomes:
Locations:
city: Galdakao
country: Spain
facility: Hospital Galdakao
state: Bizkaia
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
state: Cordoba
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
References: