Small and Large Bowel Transit Tests Using MRI (Study 1)

NCT01534507 | Completed

• 2 other identifiers: 1103811/EM/0245 (Study 1)
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome, (IBS) is a common functional disorder of the gut that can be quite disabling to patients. The most common symptoms of IBS are abdominal pain or discomfort along with erratic changes in bowel habit of diarrhoea, constipation or a mixture of the two (referred to as IBS subtypes). Despite much research efforts to further understand the pathophysiology of IBS; as yet no specific biomarkers/definitive measurements have been identified that can be use to aid the diagnosis and reduce the need for unnecessary, unpleasant and expensive tests. Evidence shows that anxiety plays a part in IBS and can speed up transit time in the small bowel. In this study, the investigators hypothesise that since anxiety is a common feature of IBS, then fast small bowel transit is likely to be found in all subtypes of IBS and the difference in stool frequency and consistency in IBS subgroups are therefore likely to reflect differences in colonic function. The investigator wish to test this by measuring both small and large bowel transit times using Magnetic Resonance Imaging (MRI) and validate the results of the MRI with two methods currently used in clinical practice -The previously validated lactose-C13 Ureide breath test (for small bowel transit) and the standard radio-opaque pellet method to assess the whole gut transit (WGT) time.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (3)

• Study 1:Correlation between mean orocaecal transit time as assessed by MRI and lactose C13-ureide

  MRI:Orocaecal transit time (OCTT) can be measured by the first scan showing arrival of the head of a meal in the ascending colon Lactose C13-Ureide breath test:Orocaecal transit time will be taken as the time at which a significant increase from background in breath 13C was seen.

  9 hours

• Study 1: Correlation between colonic transit as assessed by from the geometric centre of the PTFE capsule at time 24 and 48 hours and Metcalf Radio-opaque marker method

  Colonic transit using MRI will be measure by assessing the geometric centre position in colon/small bowel. Whole gut transit time using the Metcalf method of Radio-opaque Marker method would be estimated by counting the number of pellets remaining in the colon in an abdominal x-ray taken in day 4 \* 1.2

  72 hours

• Study 2: Fasting small bowel water content

  Fasting small bowel water content (SBWC) in the 3 subgroups of Irritable Bowel Syndrome (IBS) compared to healthy controls

  1 hour

Secondary Outcomes (7)

• Study 1:To assess reproducibility of the using MRI for orocaecal transit time and colonic transit time

  21 days

• Study 2: Orocaecal transit time using lactose C13-ureide

  9 hours

• Study 2: Area under the curve (AUC) post prandial SBWC

  9 hours

• Study 2: Ascending colon water content (ACWC) and colonic water index (CWI)

  9 hours

• Study 2: Colonic volumes both fasting and post prandial (divided into ascending transverse and descending colon)

  9 hours

Study Arms (5)

Healthy Volunteer 1 (Group 1)

For study 1 : Up to 5 healthy volunteers for the initial pilot study and further 21 healthy volunteers for the main study 1

Group 2 for study 2

Patients with diarrhoea due to irritable bowel syndrome

Group 3 for study 2

Patients with constipation due to irritable bowel syndrome

Group 4 for study 2

Patients with mixed bowel habit due to irritable bowel syndrome

Group 5 for study 2: Healthy volunteer 2

Healthy participants to act as control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers will be selected via poster advertisement Participants with Irritable Bowel Syndrome will be selected from the gastroenterology clinics /poster advertisement

You may qualify if:

• healthy volunteer
• Age 18-75 years old
• Non-smoker
• Able to give informed consent

You may not qualify if:

• Lactose intolerant
• Any history of gastrointestinal surgery on the small bowel (excluding appendicectomy)
• Pregnancy
• contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury alcohol dependence
• serious concomitant illness as judged by the investigators
• use of drugs known to alter GI motility including opiates, anti-depressants, selective serotonin reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test
• inability to lie flat or exceed scanner limits of weight \>120kg or abdominal circumference \>99cm ; BMI \<18 and \>30 kg/m2
• Poor command of English language
• Participation of any medical trials for the past 3 months
• Study 2:
• participants consisting of: 30 patients with diarrhoea predominant IBS according to Rome III criteria 30 patients with constipation predominant IBS according to Rome III criteria 30 patients with mixed type IBS according to Rome III criteria 30 healthy volunteers age and sex matched controls
• Meet the Rome III criteria and the IBS subtypes
• Age 18-75 years old
• Able to give informed consent
• Subjects will undergo a limited screening medical. They will also complete a MRI - safety questionnaire and be given an information sheet

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, Notts, NG7 2UH, United Kingdom

Location

Related Publications (2)

• Metcalf AM, Phillips SF, Zinsmeister AR, MacCarty RL, Beart RW, Wolff BG. Simplified assessment of segmental colonic transit. Gastroenterology. 1987 Jan;92(1):40-7. doi: 10.1016/0016-5085(87)90837-7.

  PMID: 3023168 BACKGROUND

• Chaddock G, Lam C, Hoad CL, Costigan C, Cox EF, Placidi E, Thexton I, Wright J, Blackshaw PE, Perkins AC, Marciani L, Gowland PA, Spiller RC. Novel MRI tests of orocecal transit time and whole gut transit time: studies in normal subjects. Neurogastroenterol Motil. 2014 Feb;26(2):205-14. doi: 10.1111/nmo.12249. Epub 2013 Oct 25.

  PMID: 24165044 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Study 1: no samples Study 2: no samples

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Robin Spiller, MD FRCP

  University of Nottingham

  STUDY DIRECTOR

• Ching Lam, MBchB MRCP

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 16, 2012
• Study Start: November 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

GB (1)