MAgnetic Resonance Imaging in COeliac Disease

NCT02551289 | Completed

• 1 other identifier: 14MP002
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease; Coeliac Disease; Celiac Sprue; Gluten Enteropathy

Keywords

MRI; Gluten; Imaging; Enteropathy-Associated T-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Colon volume

  12 months after initiation of gluten free diet

• Gut transit time

  12 months after initiation of gluten free diet

Other Outcomes (1)

• Breath hydrogen

  12 months approximately after recruitment

Study Arms (2)

Patients

Patients newly diagnosed with Coeliac disease before starting treatment with a gluten free diet

Other: Gluten free diet

Healthy volunteers

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

Interventions

Gluten free diet OTHER

Patients will follow a gluten free diet

Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Pilot study in healthy volunteers:
• Healthy volunteers (without any comorbidities)
• Able to give informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham University Hospitals NHS Trust: collaborator
• University of Salerno: collaborator

Study Sites (1)

NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust and the University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (6)

• 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. doi: 10.1002/jmri.20436.

  PMID: 16193473 BACKGROUND

• 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. doi: 10.1088/0031-9155/52/23/009. Epub 2007 Nov 8.

  PMID: 18029983 BACKGROUND

• 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.

  PMID: 24131490 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 BACKGROUND

• 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.

  PMID: 21276139 BACKGROUND

• Costigan CM, Warren FJ, Duncan AP, Hoad CL, Lewis N, Hill T, Crooks CJ, Morgan PS, Ciacci C, Iovino P, Sanders DS, Hildebrand F, Gowland PA, Spiller RC, Marciani L. One Year of Gluten-Free Diet Impacts Gut Function and Microbiome in Celiac Disease. Clin Gastroenterol Hepatol. 2025 Aug;23(9):1525-1534.e14. doi: 10.1016/j.cgh.2024.11.006. Epub 2024 Dec 9.

  PMID: 39662692 DERIVED

Related Links

• For more information on the NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust and the University of Nottingham

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool sample

MeSH Terms

Conditions

Celiac Disease; Enteropathy-Associated T-Cell Lymphoma

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Luca Marciani, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 16, 2015
• Study Start: January 1, 2016
• Primary Completion: October 19, 2018
• Study Completion: September 30, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

GB (1)