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

NCT02772458 | Completed

• 1 other identifier: 14038
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

Crohn's Disease; gut brain axis; reduced appetite

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  3 years

Study Arms (2)

Crohn's Disease

EXPERIMENTAL

Active Crohn's Disease

Other: Dodecanoate acid and saline

Healthy

EXPERIMENTAL

Healthy volunteers

Other: Dodecanoate acid and saline

Interventions

Dodecanoate acid and saline OTHER

Test drink

Crohn's Disease; Healthy

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (2)

University of Nottingham

Nottingham, NG7 2RD, United Kingdom

Location

University of Nottingham

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease; Anorexia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: May 13, 2016
• Study Start: June 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)