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Magnetic Resonance Imaging of Motility in Crohn's 1 (MIC1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717117
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:

Crohn's disease (CD) is becoming more common. One of the main features of this disease is weight loss and malnutrition with symptoms such as tummy aches and bloating. These problems have a strong negative effect on the patients' quality of life but the causes of these problems are not well understood.

Enteroendocrine cells are nutrient sensors in the bowel that secrete special chemicals (called hormones) that control appetite and the movements all the gut. The investigators think that this control mechanism goes wrong in Crohn's patients and they have set off to do more research on this. Looking at the inside work of the gut has always been difficult and at times unpleasant for patients, however recent developments in magnetic resonance imaging (MRI) are allowing the investigators to study the workings of the gut in greater detail and without discomfort for the patients.

Before studying the Crohn's patients it is necessary to run a set of pilot experiments in healthy volunteers using a test meal and subsequent MRI imaging to look at the motion of the gut. This validation stage of the methodology is essential before embarking in more detailed studies in the patients.


Condition or disease Intervention/treatment Phase
Healthy Other: Soup meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Reduced Intestinal Motility in Inflammatory Crohn's Disease - Optimisation Studies in Healthy Volunteers
Study Start Date : June 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Feeding
Cream of chicken soup (400g) (or mushroom for vegetarians) (Heinz, Wigan, UK) used as a test meal intervention. The nutrient content /100g is: energy (kcal) 51, protein (g) 1.5, carbohydrate (g) 4.7, fat (g) 2.93
Other: Soup meal
Soup meal as above




Primary Outcome Measures :
  1. Small bowel motility [ Time Frame: From fasting baseline to 270 min postprandially ]
    MRI small bowel motility index (arbitrary units)


Secondary Outcome Measures :
  1. Gall bladder contraction [ Time Frame: From fasting baseline to 60 min postprandially ]
    Gall bladder contraction from MRI images

  2. Gastric volumes [ Time Frame: From fasting baseline to 150 min postprandially ]
    Gastric emptying from gastric volumes time courses

  3. Small bowel water content [ Time Frame: From fasting baseline to 270 min postprandially ]
    Small bowel water content from MRI images

  4. Whole gut transit [ Time Frame: 24 hours after ingestion of the MRI transit capsules ]
    Whole gut transit weighted average position scores

  5. Plasma GLP-1 [ Time Frame: From fasting baseline to 270 min postprandially ]
    Postprandial GLP-1 peptide response

  6. Plasma PYY [ Time Frame: From fasting baseline to 270 min postprandially ]
    Postprandial PYY peptide response

  7. Plasma CCK [ Time Frame: From fasting baseline to 270 min postprandially ]
    Postprandial CCKpeptide response

  8. Satiety [ Time Frame: From fasting baseline to 270 min postprandially ]
    Satiety VAS scores



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Body Mass Index (BMI): 18-30 Kg/m2

Exclusion Criteria:

  • Patients with a history of inflammatory bowel disease.
  • Smokers.
  • A history of bowel resections or any gastric surgery.
  • History of pancreatic insufficiency, thyroid disease or/and diabetes.
  • Protein-pump inhibitor usage or any medication that affects gastric emptying or small bowel transit.
  • Any potential participants scoring very highly on the depression scale questionnaire.
  • Standard MRI exclusion criteria (e.g. pacemaker).
  • Malignant disease
  • Stricturing or penetrating disease
  • Smoking history
  • History of bowel resections or any gastric surgery
  • Significant cardiovascular or respiratory disease
  • Current Infection
  • Neurological or cognitive impairment
  • Significant physical disability
  • Significant hepatic disease or renal failure
  • Subjects currently (or in the last three months) participating in another research project
  • pregnancy or breastfeeding

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): NCT02717117


Locations
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United Kingdom
Nottingham Digestive Diseases Centre, QMC Campus, Nottingham University Hospitals
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Gordon W Moran, PhD University of Nottingham
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02717117    
Other Study ID Numbers: H19062014
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Nottingham:
Motility
MRI
Gut peptides
Feeding