MAgnetic Resonance Imaging in COeliac Disease

Launched by UNIVERSITY OF NOTTINGHAM · Sep 15, 2015

Keywords

ClinConnect Summary

Hypotheses of the study

Based on the investigators' pilot data and on the literature available, this study aims to test the main hypotheses that in adults newly diagnosed with coeliac disease treatment with GFD will:

1. reduce the water content of the fasting small bowel
2. reduce the volume of the fasting colon
3. increase whole gut transit time

Objectives of the study

The specific objectives of the study are therefore to quantify any change following treatment with a gluten-free diet (GFD) in:

1. the water content of the fasting small bowel
2. fasting colon volume
3. whole gut transi...

Gender

ALL

Eligibility criteria

• Inclusion:
• Patients newly diagnosed with coeliac disease:
• • Male or female
• • Able to give informed consent
• • Able to schedule the first MRI scan (Visit 2 of the study) within a month of having had a duodenal biopsy and not yet commenced on a gluten free diet.
• • Inclusion
• Pilot study in healthy volunteers:
• • Healthy volunteers (without any comorbidities)
• • Able to give informed consent
• • Exclusion Pilot study in patients
• • Any past serious, unstable medical condition, unstable/uncontrolled diabetes mellitus, major psychiatric diagnosis
• • Any reported history of gastrointestinal surgery that could affect gastrointestinal function (colectomy, small bowel resection)
• • Pregnancy declared by candidate
• • Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
• • Reported alcohol dependence
• • Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test. The following medications can be permitted during the course of the study, as long as they have been used at a constant dosage and were commenced at least 1 month prior to the start of the study: birth control pill, or depot intramuscular contraceptive preparation, oestrogen-progesterone replacement therapy, L-thyroxine, lowdose antidepressants (up to 25 mg day) of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor), or antihypertensive in the diuretic, angiotensin converting enzyme inhibitor or angiotensin II inhibitor classes. Antibiotic or probiotic treatment in the past 4 weeks
• • Inability to lie flat or exceed scanner limits of weight \<120kg
• • Poor understanding of English language
• • Participation of any medical trials for the past 3 months
• • Judgement by the PI that the candidate who will be unable to comply with the full study protocol e.g. severe COPD
• • Noncompliance to gluten free diet after first, untreated MRI.
• • Exclusion
• Healthy volunteers:
• • Serology positive test for coeliac disease markers
• • Any reported history of gastrointestinal surgery that could affect gastrointestinal function (colectomy, small bowel resection)
• • Presence of an intestinal stoma
• • Pregnancy declared by candidate
• • Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
• • Reported alcohol dependence
• • Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test. The following medications can be permitted during the course of the study, as long as they have been used at a constant dosage and were commenced at least 1 month prior to the start of the study: birth control pill, or depot intramuscular contraceptive preparation, oestrogen-progesterone replacement therapy, L-thyroxine, lowdose antidepressants (up to 25 mg day1 of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor), or antihypertensive in the diuretic, angiotensin converting enzyme inhibitor or angiotensin II inhibitor classes.
• • Proton Pump Inhibitor (PPI), antibiotic or probiotic treatment in the past 12 weeks
• • Inability to lie flat or exceed scanner limits of weight \<120kg
• • Poor understanding of English language
• • Participation of any medical trials for the past 3 months