Celiac Disease Clinical Trial
— MARCOOfficial title:
MRI Assessment in Newly Diagnosed Coeliac Disease and Following Gluten-free Diet Treatment
NCT number | NCT02551289 |
Other study ID # | 14MP002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | September 30, 2019 |
Verified date | April 2020 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
One in 100 people suffers from coeliac disease. It affects the lining of the bowel and causes
many symptoms such as diarrhoea, wind, stomach pain, constipation and nausea. The only
treatment so far is a strict glutenfree diet for life which reverses the bowel damage and
often improves symptoms. Up to 25% of patients however may have persistent symptoms despite
the gluten free diet but the reasons for this are not clear.
This research aims to help us understand how the gluten free diet works. Investigators will
use medical imaging (magnetic resonance imaging or MRI) to measure the volumes of fluid in
the small bowel, the size of the large bowel and the time it takes for foods to go through
the entire bowel in patients who have just been diagnosed with coeliac disease by their
hospital doctor. Investigators will also carry out a breath test and collect a stool sample
for basic analysis of the stool bacteria.
Investigators will also collect questionnaires about their feelings and their bowel habits
and will try to see how the MRI measurements relate to the patients' symptoms. Investigators
will observe how all these measures change after one year of the gluten free diet that
doctors will have prescribed as part of the coeliac patients' standard care. As such there is
no dietary intervention in this study, investigators will simply study changes in the
patients due to their standard treatment. Investigators will also look at a matched group of
healthy volunteers to gather a likely reference range of the measurements. This research will
be carried out in Nottingham with the help of the specialist coeliac clinics and it will last
3 years. There is a dedicated Coeliac Patient Public Involvement group who have helped plan
this study.
Status | Completed |
Enrollment | 72 |
Est. completion date | September 30, 2019 |
Est. primary completion date | October 19, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust and the University of Nottingham | Nottingham |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | Nottingham University Hospitals NHS Trust, University of Salerno |
United Kingdom,
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Hoad CL, Marciani L, Foley S, Totman JJ, Wright J, Bush D, Cox EF, Campbell E, Spiller RC, Gowland PA. Non-invasive quantification of small bowel water content by MRI: a validation study. Phys Med Biol. 2007 Dec 7;52(23):6909-22. Epub 2007 Nov 8. — View Citation
Marciani L, Coleman NS, Dunlop SP, Singh G, Marsden CA, Holmes GK, Spiller RC, Gowland PA. Gallbladder contraction, gastric emptying and antral motility: single visit assessment of upper GI function in untreated celiac disease using echo-planar MRI. J Magn Reson Imaging. 2005 Nov;22(5):634-8. — View Citation
Marciani L. Assessment of gastrointestinal motor functions by MRI: a comprehensive review. Neurogastroenterol Motil. 2011 May;23(5):399-407. doi: 10.1111/j.1365-2982.2011.01670.x. Epub 2011 Jan 30. Review. — View Citation
Pritchard SE, Marciani L, Garsed KC, Hoad CL, Thongborisute W, Roberts E, Gowland PA, Spiller RC. Fasting and postprandial volumes of the undisturbed colon: normal values and changes in diarrhea-predominant irritable bowel syndrome measured using serial MRI. Neurogastroenterol Motil. 2014 Jan;26(1):124-30. doi: 10.1111/nmo.12243. Epub 2013 Oct 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Breath hydrogen | Excretion of H2 (hydrogen) gas in breath, measured in parts per million (ppm). | 12 months approximately after recruitment | |
Primary | Fasting small bowel water content (SBWC) | Fasting small bowel water content (SBWC) measured in ml approximately 12 months after initiation of GFD | 12 months | |
Secondary | Colon volume | Fasting colon volume measured in ml | 12 months after initiation of gluten free diet | |
Secondary | Gut transit time | Whole gut transit time measured in hours | 12 months after initiation of gluten free diet |
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