Rome IV Diagnostic Criteria
Research type
Research Study
Full title
Multi-Center Validation Study of the Rome IV Diagnostic Criteria for Functional Gastrointestinal Disorders
IRAS ID
172961
Contact name
Peter Whorwell
Contact email
Sponsor organisation
Rome Foundation inc,
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Unfortunately, there is no diagnostic test for functional gastrointestinal disorders (FGIDs) and consequently we are dependant on the patients' symptoms for making a diagnosis. Over the years, a number of different diagnostic questionnaires have been developed of which the Rome diagnostic criteria have been the most commonly used. The Rome III criteria are the ones that are in current use but recently the Rome IV criteria have been developed in the hope that they will be the most accurate criteria developed to date.
The purpose of this study is to assess how well the new Rome IV criteria agree with the clinical diagnosis made by an experienced gastroenterologist. This study will be performed in a number of different centres in the UK, Canada and the USA.
The Functional Gastrointestinal Disorders that will be studied are 25 Irritable Bowel Syndrome, 25 Functional Dyspepsia, 25 Functional Constipation, plus patients with any other Functional Gastrointestinal Disorders available to complete a total site sample of 100.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0202
Date of REC Opinion
30 Apr 2015
REC opinion
Favourable Opinion