Caecal pH as a biomarker for irritable bowel syndrome
Research type
Research Study
Full title
A randomised controlled trial to validate the use of caecal pH measurement as a biomarker in irritable bowel syndrome
IRAS ID
170125
Contact name
Anthony Hobson
Contact email
Sponsor organisation
Functional Gut Clinic
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Irritable bowel syndrome (IBS) is an extremely common condition. IBS can be sub-classified based upon predominating bowel habit, i.e. constipation predominant (IBS-C), alternating bowel habit (IBS-A) or diarrhoea predominant. In recent years, several efficacious treatment approaches have been applied to IBS including dietary interventions (low fibre and low fermentable oligosaccharides, disaccha¬rides, monosaccharides and polyols (FODMAP)), probiotics (VSL#3) and pharmacological agents (linaclotide) (3). Whilst each of these treatment approaches have shown efficacy, it is clear that further refinement of the IBS diagnostic algorithm is required to better target therapies in order to overcome the inherent differences within the IBS population. In this study we propose to evaluate the effect of the low FODMAP diet against placebo and lincalotide in IBS-A and IBS-C respectively on acidity in the bowel as assessed by a wireless capsule. All the interventions in the trial are being used within their current accepted indications.The primary aim of this study is to demonstrate that the measurement of bowel acidity (caecal pH) is a sensitive and reliable biomarker of caecal fermentation in IBS and that normalisation of the caecal pH environment will correlate with symptomatic improvement in IBS patients. We hypothesise that normalisation of the caecal pH environment with either dietary intervention or linaclotide will correlate with symptomatic improvement in IBS patients. The results from such a study could potential allow doctors to stratify treatments.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0258
Date of REC Opinion
23 Sep 2015
REC opinion
Further Information Favourable Opinion