MAgnetic Resonance Imaging in COeliac Disease (MARCO)
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|ClinicalTrials.gov Identifier: NCT02551289|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2015
Last Update Posted : April 25, 2019
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.
|Condition or disease||Intervention/treatment|
|Celiac Disease Coeliac Disease Celiac Sprue Gluten Enteropathy||Other: Gluten free diet|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||72 participants|
|Official Title:||MRI Assessment in Newly Diagnosed Coeliac Disease and Following Gluten-free Diet Treatment|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||October 19, 2018|
|Estimated Study Completion Date :||September 30, 2019|
Patients newly diagnosed with Coeliac disease before starting treatment with a gluten free diet
Other: Gluten free diet
Patients will follow a gluten free diet
Participants who do not meet criteria for a clinical diagnosis of Coeliac disease as determined by screening blood sample.
- Fasting small bowel water content (SBWC) [ Time Frame: 12 months ]Fasting small bowel water content (SBWC) measured in ml approximately 12 months after initiation of GFD
- Colon volume [ Time Frame: 12 months after initiation of gluten free diet ]Fasting colon volume measured in ml
- Gut transit time [ Time Frame: 12 months after initiation of gluten free diet ]Whole gut transit time measured in hours
- Breath hydrogen [ Time Frame: 12 months approximately after recruitment ]Excretion of H2 (hydrogen) gas in breath, measured in parts per million (ppm).
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551289
|NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust and the University of Nottingham|
|Nottingham, United Kingdom, NG7 2UH|
|Principal Investigator:||Luca Marciani, PhD||University of Nottingham|