Reclassifying Constipation Using Imaging and Manometry

Summary

Constipation is a common condition in which an individual suffers with hard stools which are infrequent and difficult to pass. It is poorly understood and treatment is often unsatisfactory. Many patients also experience pain whilst others do not but it is unclear why . It is believed that the pain arises from contractions in the colon, the lower part of the intestines. Some patients with constipation have weak colonic contraction but surprisingly some, particularly those with a lot of pain have strong contractions which are poorly coordinated. These patients all suffer from constipation but would are likely to need very different treatments. At present we cannot identify what type of abnormality of colonic contractions each individual patient suffers from and so are unable to give them the best treatment. This study will take advantage of two new techniques which have been recently developed. Magnetic Resonance Imaging (MRI) which will allow us to see the contractions of the colon in response to a dose of the laxative Moviprep which increases the flow of fluid into the proximal part of the colon and High Resolution Manometry (HRM) which measures the power and direction of the contraction in much more detail than ever before using a pressure sensing catheter placed into the bowel. Using these 2 techniques we will identify the pattern of contractions in 80 patients with constipation and 40 healthy controls. Participants will then enter into a controlled trial of either a drug which stimulates contractions or one which inhibits contraction. We anticipate that the pattern of contractions identified by the non-invasive MRI technique will predict which treatment will reduce their symptoms most as effectively as the more invasive HRM. If this is the case then our MRI test of colonic responsiveness could become widely used in routine clinical practice

Conditions

• Constipation - Functional
• Irritable Bowel Syndrome Characterized by Constipation

Interventions

PROCEDURE

MRI Motility

MRI sequence to assess colonic motility

PROCEDURE

High Resolution Manometry

HRM of colon to assess motility

DRUG

Bisacodyl

Given as agent to monitor effect on symptoms and then to compare with motility data. Drug itself not being tested.

DRUG

Hyoscine butylbromide

Given as agent to monitor effect on symptoms and then to compare with motility data. Drug itself not being tested.

Sponsors & Collaborators

• University College, London

  collaborator OTHER

• Queen Mary University of London

  collaborator OTHER

• University of Nottingham

  lead OTHER

Principal Investigators

• Robin Spiller · University of Nottingham

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-07-20

Primary Completion

2020-09-30

Completion

2021-06-30

Countries

• United Kingdom

Study Locations