NCT03955328

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

June 15, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

May 10, 2019

Last Update Submit

May 15, 2019

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Patient reported outcomes on IBDQ-32 questionnaire

    Baseline

  • Patient reported outcomes on EQ-5D-5L questionnaire

    Baseline

  • Patient reported outcomes on Work Productivity and Activity questionnaire

    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

  • +8 more secondary outcomes

Study Arms (1)

Magnetic Resonance Imaging

EXPERIMENTAL

A magnetic resonance imaging is perform to detect permanent anatomical damage.

Diagnostic Test: Magnetic Resonance Imaging

Interventions

Magnetic Resonance ImagingDIAGNOSTIC_TEST

A magnetic resonance imaging is perform to detect permanent anatomical damage.

Magnetic Resonance Imaging

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Galdakao

Galdakao, Bizkaia, 48960, Spain

Location

Hospital Reina Sofía

Córdoba, Cordoba, 14004, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Julia Panes, MD

CONTACT

93.227.54.00jpanes@clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Fundació Clínic per la Recerca Biomèdica

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 20, 2019

Study Start

June 15, 2019

Primary Completion

December 31, 2019

Study Completion

June 15, 2020

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

ES(4)