Validation of Magnetic Resonance Imaging to Characterise Gastrointestinal Physiology, Gut Luminal Content and Its Interaction With Colonic Microbiota in Patients With Chronic Constipation

University of Nottingham2 sites in 1 country24 target enrollmentMarch 2014

ConditionsConstipation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Constipation
Sponsor: University of Nottingham
Enrollment: 24
Locations: 2
Primary Endpoint: Weighted Average Position Score of transit marker capsules as determined by MRI
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to test how well magnetic resonance imaging (MRI) can measure whole gut transit time in people with constipation, and how readily it can detect a change in transit time induced by taking a dietary supplement with laxative effects.The investigators expect to demonstrate that ispaghula (psyllium) accelerates movement of matter through the intestinal tract.

The investigators will also assess whether a change in gut bacteria and the chemicals that they release can be detected.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

June 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Nottingham

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Meets Rome III Criteria for diagnosis of Functional Constipation5 on questionnaire (NB. Both those who do and do not meet IBS criteria will be eligible)
•At least one bowel motion per week while taking usual laxatives
•Able to give informed consent
•Aged 18 or older

Exclusion Criteria

•History declared by the candidate of other pre-existing gastrointestinal disorder, including but not limited to:
•Inflammatory Bowel Disease
•Coeliac Disease diagnosed in the last year
•Pancreatitis
•Cancer of the gastrointestinal tract
•Any reported history of gastrointestinal resection (excluding appendicectomy or cholecystectomy)
•Presence of an intestinal stoma
•Pregnancy declared by candidate (no formal testing)
•Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
•Reported alcohol intake of \>28 units/ week with daily drinking

Outcomes

Primary Outcomes

Weighted Average Position Score of transit marker capsules as determined by MRI

Time Frame: 24 hours after ingestion

After 4 days of study product participants will ingest 5 transit mark capsules, the use of which has been shown to measure whole gut transit in a similar manner to more established techniques. They will continue to take study product before undergoing an MRI scan to assess capsule position

Secondary Outcomes

Weighted Average Position Score of 5 transit marker capsules, as determined by MRI(48 hours after ingestion)
Small Bowel Water Content (SBWC) in millilitres(mL) measured by MRI(-60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal)
Small Bowel Water Content (SBWC) in millilitres measured by MRI(Baseline, 60 minutes before test meal)
Ascending Colon Water Content in millilitres measured by MRI(-60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal)
Change from baseline in Ascending Colon Water Content in millilitre measured by MRI(test meal -60, test meal +60)
Change from before to after challenge meal in Ascending Colon Water Content before in millilitre measured by MRI(test meal +360 minutes, test meal + 420 minutes)
Ascending Colon T1(-60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal)
Descending Colon T1(-60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal)
Ascending colon T2(-60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal)
Descending Colon T2(-60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal)