Stratification of Irritable Bowel Syndrome
Research type
Research Study
Full title
Stratification of Irritable Bowel Syndrome by profiling the faecal microbiota composition and urine metabolome
IRAS ID
231363
Contact name
Alexander C. Ford
Contact email
Sponsor organisation
4D pharma plc
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Irritable bowel syndrome (IBS) is the most common functional gastrointestinal (GI) disorder diagnosed by gastroenterologists with worldwide prevalence rates of 10–15%. The condition accounts for up to 3% of total visits to primary care providers. The cost to society in terms of direct medical expenses and indirect costs associated with loss of productivity and work absenteeism is considerable, estimated in the range of $21 billion or more annually. IBS is characterized by abdominal pain or discomfort in association with alteration in either stool form or frequency. These symptoms can be debilitating and lead to a significant reduction in quality of life particularly in the more severely affected. The exact pathophysiology of IBS has not been fully elucidated. It is therefore diagnosed solely on the basis of patient-reported symptoms, when obvious biochemical and anatomic pathology have been excluded, since no biomarkers have been identified to date. Recently, alterations of gut microbiota have been proposed as a possible causal factor for IBS. A growing number of studies demonstrate that the diversity, stability, and metabolic activity of the gut microbiota are altered in most patients with IBS, compared with healthy individuals. Although all studies describe shifts in the relative abundance of certain bacteria, to date, no microbial signature has been identified that confidently distinguishes individuals with IBS from those who are healthy.
The aim of the study is to stratify IBS patients by profiling the faecal microbiota composition and urine metabolomics to improve clinical diagnosis and treatment strategies. The study will recruit patients with IBS and healthy control subjects in a hospital over an 18-month period. Healthy control subjects are required as a control population to develop the diagnostic test for clinical utility in IBS patients.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0419
Date of REC Opinion
21 Nov 2017
REC opinion
Favourable Opinion