NCT03052465

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. Our main objective is to investigate the difference in small bowel motility between CD patients with active ileal disease and healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

November 16, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2017

Completed
Last Updated

October 25, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

February 9, 2017

Last Update Submit

October 24, 2017

Conditions

Crohn Disease

Keywords

Motility

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure: MRI small bowel motility index (arbitrary units)

    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

  • Plasma GLP-1

    From fasting baseline to 270 min postprandially

  • Plasma PYY

    From fasting baseline to 270 min postprandially

  • +3 more secondary outcomes

Study Arms (1)

Feeding

EXPERIMENTAL

Test soup meal feeding intervention

Other: Test soup meal feeding intervention

Interventions

Test soup meal feeding interventionOTHER

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

Feeding

Eligibility Criteria

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

You may qualify if:

  • patients with active Cronh's disease
  • Body Mass Index (BMI): 18-30 Kg/m2

You may not qualify if:

  • 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
  • Subjects currently (or in the last three months) participating in another research project
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham Digestive Diseases Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (1)

  • Khalaf A, Hoad CL, Menys A, Nowak A, Radford S, Taylor SA, Latief K, Lingaya M, Falcone Y, Singh G, Spiller RC, Gowland PA, Marciani L, Moran GW. Gastrointestinal peptides and small-bowel hypomotility are possible causes for fasting and postprandial symptoms in active Crohn's disease. Am J Clin Nutr. 2020 Jan 1;111(1):131-140. doi: 10.1093/ajcn/nqz240.

    PMID: 31557279DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Asseel Khalaf, MSc

    University of Nottingham

    STUDY DIRECTOR

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

February 9, 2017

First Posted

February 14, 2017

Study Start

November 16, 2015

Primary Completion

March 7, 2017

Study Completion

March 7, 2017

Last Updated

October 25, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)