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

NCT ID: NCT02772458

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-09-30

Brief 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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Crohn's Disease

Active Crohn's Disease

Group Type: EXPERIMENTAL

Dodecanoate acid and saline

Intervention Type: OTHER

Test drink

Healthy

Healthy volunteers

Group Type: EXPERIMENTAL

Dodecanoate acid and saline

Intervention Type: OTHER

Test drink

Interventions

Dodecanoate acid and saline

Test drink

Intervention Type: OTHER

Eligibility Criteria

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

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

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Nottingham

Nottingham, , United Kingdom

University of Nottingham

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

14038

Identifier Type: -

Identifier Source: org_study_id