NCT02717117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

March 17, 2016

Last Update Submit

January 4, 2017

Conditions

Healthy

Keywords

MotilityMRIGut peptidesFeeding

Outcome Measures

Primary Outcomes (1)

  • Small bowel motility

    MRI small bowel motility index (arbitrary units)

    From fasting baseline to 270 min postprandially

Secondary Outcomes (8)

  • Gall bladder contraction

    From fasting baseline to 60 min postprandially

  • Gastric volumes

    From fasting baseline to 150 min postprandially

  • Small bowel water content

    From fasting baseline to 270 min postprandially

  • Whole gut transit

    24 hours after ingestion of the MRI transit capsules

  • Plasma GLP-1

    From fasting baseline to 270 min postprandially

  • +3 more secondary outcomes

Study Arms (1)

Feeding

EXPERIMENTAL

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

Interventions

Soup mealOTHER

Soup meal as above

Feeding

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham Digestive Diseases Centre, QMC Campus, Nottingham University Hospitals

Nottingham, NG7 2UH, United Kingdom

Location

Study Officials

  • Gordon W Moran, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 23, 2016

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 5, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)