Caecal pH as a Biomarker for Irritable Bowel Syndrome

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wingate Institute of Neurogastroenterology
• Treatments: Linaclotide

Criteria

Inclusion Criteria:

• Ability to provide Informed written consent

• Age (18-65 years old)

• Male and female patients with irritable bowel syndrome of the alternating or constipation subtype.

Exclusion Criteria:

• Any inclusion criteria not met

• Participants unable to provide informed consent.

• Participants on any medications that may influence gastrointestinal motility (e.g. beta-agonists).

• Pregnancy.

• Recent antibiotic use in the preceding 4 weeks.

• Recent probiotic use in the last 2 weeks, concurrent use of promotile medications.

• Participants with IBS-C who are already taking linaclotide or have known hypersensitivity to linaclotide.

• History of a systemic disorder with known gastrointestinal manifestations (such as diabetes mellitus, connective tissue disorders etc.) and previous gastrointestinal tract surgery will be treated as criteria for exclusion. Specific contraindications to WMC are dysphagia, recent abdominal surgery, Crohn's disease, planned MRI and diverticulitis.