Progression of Damage in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— PRODUC  

Official title:

Progression of Damage in Ulcerative Colitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03955328
• Other study ID #: HCB/2017/0842
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: May 2019
• Source: Hospital Clinic of Barcelona
• Contact: Julia Panes, MD
• Phone: 93.227.54.00
• Email: jpanes[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 15, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Diagnostic Test:
• Magnetic Resonance Imaging
A magnetic resonance imaging is perform to detect permanent anatomical damage.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Reina Sofía	Córdoba	Cordoba
Spain	Hospital Galdakao	Galdakao	Bizkaia
Spain	Hospital Puerta de Hierro	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
David Garcia Cinca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Patient reported outcomes on Disability Index questionnaire		Baseline
Secondary	To identify disease characteristics associated with permanent/accumulated damage disease severity with number of f the hospital admissions		Baseline
Secondary	To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of corticoesteroids		Baseline
Secondary	To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of immunosuppressants		Baseline
Secondary	To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of biologics drugs		Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	To identify disease characteristics associated with permanent/accumulated damage with the time since the disease diagnosis		Baseline
Secondary	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