Progression of Damage in Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-15

Study Completion Date

2020-06-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Magnetic Resonance Imaging

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

Group Type EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Magnetic Resonance Imaging

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No