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Progression of Damage in Ulcerative Colitis (PRODUC)

Primary Purpose

Ulcerative Colitis

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Magnetic Resonance Imaging
Sponsored by
David Garcia Cinca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Galdakao
  • Hospital Reina Sofía
  • Hospital Puerta de Hierro
  • Hospital Clínic de Barcelona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetic Resonance Imaging

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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)
Patient reported outcomes on Disability Index questionnaire
To identify disease characteristics associated with permanent/accumulated damage disease severity with number of f the hospital admissions
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of corticoesteroids
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of immunosuppressants
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of biologics drugs
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
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
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
To identify disease characteristics associated with permanent/accumulated damage with the time since the disease diagnosis
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.

Full Information

First Posted
May 10, 2019
Last Updated
May 15, 2019
Sponsor
David Garcia Cinca
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1. Study Identification

Unique Protocol Identification Number
NCT03955328
Brief Title
Progression of Damage in Ulcerative Colitis
Acronym
PRODUC
Official Title
Progression of Damage in Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2019 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
June 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Garcia Cinca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnetic Resonance Imaging
Arm Type
Experimental
Arm Description
A magnetic resonance imaging is perform to detect permanent anatomical damage.
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
A magnetic resonance imaging is perform to detect permanent anatomical damage.
Primary Outcome Measure Information:
Title
Relationship of structural changes in colon morphology and functional changes assessed by MRI with disease duration in UC patients in clinical remission
Description
Explorative structural changes
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Patient reported outcomes on IBDQ-32 questionnaire
Description
Inflammatory bowel diseases health-related quality of life index which is a questionnaire of 32 items, score ranges from 32 to 224.
Time Frame
Baseline
Title
Patient reported outcomes on EQ-5D-5L questionnaire
Description
EQ-5D-5L questionnaire a standardized instrument for measuring generic health status, score ranges from -0.224 to 1.
Time Frame
Baseline
Title
Patient reported outcomes on Work Productivity and Activity questionnaire
Description
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)
Time Frame
Baseline
Title
Patient reported outcomes on Disability Index questionnaire
Time Frame
Baseline
Title
To identify disease characteristics associated with permanent/accumulated damage disease severity with number of f the hospital admissions
Time Frame
Baseline
Title
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of corticoesteroids
Time Frame
Baseline
Title
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of immunosuppressants
Time Frame
Baseline
Title
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of biologics drugs
Time Frame
Baseline
Title
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
Time Frame
Baseline
Title
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
Time Frame
Baseline
Title
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
Time Frame
Baseline
Title
To identify disease characteristics associated with permanent/accumulated damage with the time since the disease diagnosis
Time Frame
Baseline
Title
To identify disease characteristics associated with permanent/accumulated damage related to anorectal function using Cleveland Clinic Incontinence Score
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Panes, MD
Phone
93.227.54.00
Email
jpanes@clinic.cat
Facility Information:
Facility Name
Hospital Galdakao
City
Galdakao
State/Province
Bizkaia
ZIP/Postal Code
48960
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Arevalo, MD
Facility Name
Hospital Reina Sofía
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Iglesias, MD
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Vera, MD
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Panes, MD
First Name & Middle Initial & Last Name & Degree
Julia Panes, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Progression of Damage in Ulcerative Colitis

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