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

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.

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Key information

Conditions

Crohn's Disease Anorexia Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham, Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 16-75 years
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,
Intestinal inflammation or deep ulceration seen on CT or MR enterography, with the disease activity quantified via the MaRIA score or,
Faecal calprotectin of >250µg/g
C-Reactive protein >5mg/dl
Harvey-Bradshaw index score of 5-16
Body mass index (BMI) 18-35
As for HV participants, inclusion criteria 1 and 7 will apply.

Exclusion criteria

Malignant disease
BMI <18 and >35
Significant cardiovascular or respiratory disease
Diabetes mellitus
Current Infection
Neurological or cognitive impairment; significant physical disability
Significant hepatic disease or renal failure
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)
Subjects currently participating in (or in the last three months) any other research project
pregnancy or breastfeeding or
if MRI is contraindicated (e.g. pacemaker).
Severe Crohn's disease where a delay in a change in medical treatment for 23 weeks would not be clinically advisable.
As for healthy volunteer participants all exclusion criteria apart from no.12.

Treatment and study plan

Dodecanoate acid and saline

Other

Test drink

Primary outcomes

Changes in Blood Oxygenation Level Dependent (BOLD) response in the brain following a fatty acid test meal in Crohn's patients and healthy controls

Time frame: 3 years

Secondary outcomes

Changes in arterial spin labeling measures of cerebral blood flow and changes in gut peptide levels following the fatty acid test meal.

Time frame: 3 years
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)

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: May 13, 2016
Registry last updated: Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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