Ulcerative ColitisPRODUCNCT03955328
Progression of Damage in Ulcerative Colitis
A study testing Magnetic Resonance Imaging in people with Ulcerative Colitis, run by David Garcia Cinca at 4 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesSpain
- Study dates
- 15 Jun 2019to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Clínic de Barcelona
Barcelona, 08036
Julia Panes, MD
Julia Panes, MD
Hospital Reina Sofía
Córdoba, Cordoba, 14004
Eva Iglesias, MD
Hospital Galdakao
Galdakao, Bizkaia, 48960
Jose Arevalo, MD
Hospital Puerta de Hierro
Majadahonda, Madrid, 28222
Isabel Vera, MD
About this study
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Magnetic Resonance Imaging
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
A magnetic resonance imaging is perform to detect permanent anatomical damage.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Resonance Imaging | Experimental | A magnetic resonance imaging is perform to detect permanent anatomical damage. Receives: Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (13)
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.
Measured: Baseline
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.
Measured: Baseline
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)
Measured: Baseline
Patient reported outcomes on Disability Index questionnaire
Measured: Baseline
To identify disease characteristics associated with permanent/accumulated damage disease severity with number of f the hospital admissions
Measured: Baseline
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of corticoesteroids
Measured: Baseline
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of immunosuppressants
Measured: Baseline
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of biologics drugs
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
To identify disease characteristics associated with permanent/accumulated damage with the time since the disease diagnosis
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start15 Jun 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion15 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Garcia Cinca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Garcia Cinca, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955328
- Sponsor's protocol ID
- HCB/2017/0842
- Acronym
- PRODUC
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Damage in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03955328
- Acronym / sponsor ID
- PRODUC / HCB/2017/0842
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- David Garcia CincaUniversity, hospital or other
- Study start
- 15 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 15 Jun 2020 (estimated)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Resonance Imaging | Experimental | Diagnostic Test: Magnetic Resonance ImagingA magnetic resonance imaging is perform to detect permanent anatomical damage. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingA magnetic resonance imaging is perform to detect permanent anatomical damage. | Diagnostic test | Magnetic Resonance Imaging |
Primary outcome
Relationship of structural changes in colon morphology and functional changes assessed by MRI with disease duration in UC patients in clinical remission
Time frame: Baseline
Explorative structural changes
13 secondary outcomes
Patient reported outcomes on IBDQ-32 questionnaire
Time frame: Baseline
Patient reported outcomes on EQ-5D-5L questionnaire
Time frame: Baseline
Patient reported outcomes on Work Productivity and Activity questionnaire
Time frame: Baseline
Patient reported outcomes on Disability Index questionnaire
Time frame: Baseline
To identify disease characteristics associated with permanent/accumulated damage disease severity with number of f the hospital admissions
Time frame: Baseline
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of corticoesteroids
Time frame: Baseline
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of immunosuppressants
Time frame: Baseline
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of biologics drugs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline
To identify disease characteristics associated with permanent/accumulated damage with the time since the disease diagnosis
Time frame: Baseline
To identify disease characteristics associated with permanent/accumulated damage related to anorectal function using Cleveland Clinic Incontinence Score
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Ulcerative Colitis, run by David Garcia Cinca at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Panes, MD (93.227.54.00, jpanes@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship of structural changes in colon morphology and functional changes assessed by MRI with disease duration in UC patients in clinical remission (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.