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Caecal pH as a Biomarker for Irritable Bowel Syndrome

NCT02360384 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-11-03

No results posted yet for this study

Summary

Irritable bowel syndrome is common. Currently, it is a diagnosis of exclusion. There is increasing evidence of the importance of the microbiota in the pathophysiology of this disorder. However, it has been challenging to measure the "activity" of the microbiota in vivo as much of the GI tract is inaccessible. Fermentation by the microbiota occurs in the colon, a by product of which are short chain fatty acids. Measuring pH in the colon could potentially act as a surrogate marker of fermentation. The investigators are undertaking a randomised controlled trial in patients with IBS measuring the pH in the digestive tract using a wireless motility capsule at baseline and in response to dietary changes in patients with diarrhoea predominant IBS and in response to linaclotide in those with constipation predominant IBS to ascertain the effect of these interventions on the microbiota and clinical outcomes.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Linaclotide

Linaclotide 290mcg po od in all patients with irritable bowel syndrome with constipation.

DIETARY_SUPPLEMENT

FODMAP diet

Patients with irritable bowel syndrome with alternating bowel habit will be commenced on the either the low FODMAP diet or a control healthy eating diet.

Sponsors & Collaborators

  • Wingate Institute of Neurogastroenterology

    lead OTHER

Principal Investigators

  • Adam D Farmer, PhD MRCP · Wingate Institute of Neurogastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02360384 on ClinicalTrials.gov