Caecal pH as a Biomarker for Irritable Bowel Syndrome

NCT02360384 | Unknown

• 1 other identifier: WMC1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

wireless motility capsule

Outcome Measures

Primary Outcomes (1)

• To evaluate the change in pH around the ileocaecal valve in response to dietary intervention or linaclotide.

  Change in pH around the ileocaecal valve using the wireless motility capsule in response to the dietary intervention and linaclotide

  28 days

Secondary Outcomes (4)

• Change in caecal pH and its association with the degree in symptomatic improvement using the IBS-symptom scale

  28 days

• Motility patterns and transit in subtype IBS patients, according to the Rome III criteria, using the wireless motility capsule

  1-2 days

• The effect of the interventions on symptoms using the validated questionnaires of IBS-SSS

  28 days

• The effect of the interventions on quality of life measures using the validated Eq-5D

  28 days

Study Arms (3)

Sham diet

PLACEBO COMPARATOR

The placebo intervention will be healthy eating advice in patients with irritable bowel syndrome of the alternating subtype for 28 days.

Drug: Linaclotide

Lincalotide

ACTIVE COMPARATOR

All patients with constipation predominant IBS will receive linaclotide 280mcg po od for 28 days.

Drug: Linaclotide

FODMAP diet

EXPERIMENTAL

The FODMAP diet will be introduced in patients with irritable bowel syndrome of the alternating subtype for 28 days.

Dietary Supplement: FODMAP diet

Interventions

Linaclotide DRUG

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

Also known as: Constella

Lincalotide; Sham diet

FODMAP diet DIETARY_SUPPLEMENT

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.

FODMAP diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wingate Institute of Neurogastroenterology: lead

Study Sites (1)

Wingate Institute of Neurogastroenterology

London, London, E1 @AJ, United Kingdom

Location

Related Publications (1)

• Farmer AD, Mohammed SD, Dukes GE, Scott SM, Hobson AR. Caecal pH is a biomarker of excessive colonic fermentation. World J Gastroenterol. 2014 May 7;20(17):5000-7. doi: 10.3748/wjg.v20.i17.5000.

  PMID: 24803812 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

linaclotide; FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Adam D Farmer, PhD MRCP

  Wingate Institute of Neurogastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant gastroenterologist

Study Record Dates

• First Submitted: January 25, 2015
• First Posted: February 10, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 3, 2016

Record last verified: 2016-11

Locations

GB (1)