Reduced Appetite in Crohn's Disease: The Role of the Brain in the Control of Food Intake

Crohn's Disease Clinical Trial

Official title:

Reduced Appetite in Crohn's Disease: Investigating the Role of the Gut Brain Pathways

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772458
• Other study ID #: 14038
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: September 2018

Study information

• Verified date: October 2017
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Crohn's disease (CD) is becoming more common, specifically in the western world. One of the main features of this disease is weight loss and malnutrition. Although clinically common, these problems are not well understood. Loss of appetite and symptoms such as tummy aches and bloating are common causes for weight loss in this group of patients. This problem has a strong negative effect on the patients' quality of life and significantly increases the cost of treating CD. Enteroendocrine cells are nutrient sensors in the bowel that relay to the brain to control food intake. Recent evidence has showed that these cells increase in number in active CD and secrete more hormones that negatively affect appetite. The increased levels of these hormones should have an overall negative effect on the brain and thus decrease food intake, bloating, symptoms of sickness. All these symptoms lead to malnutrition. These are hypotheses that require further proof. Current technological advances in magnetic resonance imaging (MRI) has enabled the mapping of changes in activity in important areas in the brain that control food intake. The involvement of the brain in control of food intake is still not fully understood. This work will be the first step in the right direction to start targeting the problems of appetite, weight loss and a poor quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 16-75 years

2. Ulceration seen at ileocolonoscopy, aiming for a simple endoscopic score for Crohn's disease (SES-CD) of 4-19, in the absence of stricturing disease or,

3. Intestinal inflammation or deep ulceration seen on CT or MR enterography, with the disease activity quantified via the MaRIA score or,

4. Faecal calprotectin of >250µg/g

5. C-Reactive protein >5mg/dl

6. Harvey-Bradshaw index score of 5-16

7. Body mass index (BMI) 18-35

8. As for HV participants, inclusion criteria 1 and 7 will apply.

Exclusion Criteria:

1. Malignant disease

2. BMI <18 and >35

3. Significant cardiovascular or respiratory disease

4. Diabetes mellitus

5. Current Infection

6. Neurological or cognitive impairment; significant physical disability

7. Significant hepatic disease or renal failure

8. Abnormal blood results other than those explained by CD including bleeding diatheses (apart from in the case of HV where all unexplained blood results are an exclusion criteria)

9. Subjects currently participating in (or in the last three months) any other research project

10. pregnancy or breastfeeding or

11. if MRI is contraindicated (e.g. pacemaker).

12. Severe Crohn's disease where a delay in a change in medical treatment for 23 weeks would not be clinically advisable.

13. As for healthy volunteer participants all exclusion criteria apart from no.12.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Other:
• Dodecanoate acid and saline
Test drink

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham
United Kingdom	University of Nottingham	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Blood Oxygenation Level Dependent (BOLD) response in the brain following a fatty acid test meal in Crohn's patients and healthy controls		3 years
Secondary	Changes in arterial spin labeling measures of cerebral blood flow and changes in gut peptide levels following the fatty acid test meal.	The increase or decrease in BOLD signal of the brain following the fatty acid stimuli will be correlated to the gut peptide levels which are listed as follows: CCK (pmol/ml); GLP-1 (pM); PYY (pg/ml); Ghrelin (ng/ml)	3 years