PRO-MC (PROspective data registry & follow-up for Microscopic Colitis)

• Research type

  Research Database

• IRAS ID

  217202

• Contact name

  Anastasios Koulaouzidis

• Contact email

  akoulaouzidis@hotmail.com

• Research summary

  PRO-MC (European PROspective data registry and follow-up for Microscopic Colitis)

• REC name

  South East Scotland REC 01

• REC reference

  16/SS/0203

• Date of REC Opinion

  31 Jul 2017

• REC opinion

  Further Information Favourable Opinion

• Data collection arrangements

  We aim to recruit adult patients with an established or new diagnosis of microscopic colitis. Patients unwilling or unable to give informed consent will not be included.

  Data to be collected:
  1. General patient data: age, gender, ethnicity, type of microscopic colitis
  2. Diagnosis: date of diagnostic endoscopy, type and indication of endoscopy procedure, presence and type of macroscopic findings
  3. Signs and symptoms
  4. Disease activity as recorded by patients between visits
  5. Diagnostic tests: microbiology, coeliac disease serology, lactose-intolerance testing, bile-acid malabsorption
  6. History: comorbidities at time of diagnosis, family history of microscopic colitis/ inflammatory bowel disease/ colorectal cancer/ coeliac disease
  7. Smoking status and alcohol consumption
  8. Treatment

  Identifiable data for patients from our individual centre (The Royal Infirmary of Edinburgh) will be stored on a single dedicated excel spreadsheet, which will be stored in an encrypted device. This identifiable data will only be handled on NHS computers. Anonymised data will be stored on a dedicated, prospectively-designed and secure online database.

• Research programme

  More studies addressing the natural disease course of microscopic colitis (MC), potential pathophysiological mechanisms, the role of non-invasive markers, and genetic predisposition in patients with MC are warranted. Therefore, large cohort studies including prospectively non-selected and well described patients are warranted. Considering the relatively low incidence rates of MC in some European countries, international collaboration is indispensable. Therefore, the aim of this project is to start a European database for MC with prospective collection clinical data on disease phenotype, disease activity, response to treatment, disease course and medication use. The PRO-MC Collaboration will establish a European, prospective cohort of well-characterized patients with a new or established diagnosis of MC. The primary aim is to describe baseline characteristics, disease course, treatment response and quality of life of the PRO-MC cohort.

• Research database title

  PRO-MC (European PROspective data registry and follow-up for Microscopic Colitis)

• Establishment organisation

  Centre for Liver and Digestive Disorders, The Royal Infirmary of Edinburgh

• Establishment organisation address

  51 Little France Crescent

  EH16 4SA