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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
Sponsor:
Collaborators:
Nottingham University Hospitals NHS Trust
University of Salerno
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Patients
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

Healthy volunteers
Participants who do not meet criteria for a clinical diagnosis of Coeliac disease as determined by screening blood sample.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Colon volume [ Time Frame: 12 months after initiation of gluten free diet ]
    Fasting colon volume measured in ml

  2. Gut transit time [ Time Frame: 12 months after initiation of gluten free diet ]
    Whole gut transit time measured in hours


Other Outcome Measures:
  1. 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
Stool sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

36 newly diagnosed coeliac disease patients.

A parallel group of 36 healthy subjects, frequency matched for age (in 20 years bands) and gender.

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

Information from the National Library of Medicine

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


Locations
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United Kingdom
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
Sponsors and Collaborators
University of Nottingham
Nottingham University Hospitals NHS Trust
University of Salerno
Investigators
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Principal Investigator: Luca Marciani, PhD University of Nottingham

Additional Information:
Publications:
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02551289     History of Changes
Other Study ID Numbers: 14MP002
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: October 2018
Keywords provided by University of Nottingham:
MRI
Gluten
Imaging
Enteropathy-Associated T-Cell Lymphoma
Additional relevant MeSH terms:
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Celiac Disease
Intestinal Diseases
Malabsorption Syndromes
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases