Progression of Damage in Ulcerative Colitis (PRODUC)

David Garcia Cinca

Status: Unknown

Conditions: Ulcerative Colitis

Treatments: Diagnostic Test: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03955328

HCB/2017/0842

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Magnetic Resonance Imaging

Experimental group

Description:

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

Treatment:

Diagnostic Test: Magnetic Resonance Imaging