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N/A N=61

Eating Behaviour in Crohn's Disease

Crohn's Disease

Enrolled (actual)
61
Serious AEs
Results posted
Jul 2019
Primary outcome: Primary: Dietary Recalls (Calorific Intake) — 1900.9; 2054.3 kcal

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
All
Sponsor
University of Nottingham
Primary completion
Jan 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Dietary Recalls (Calorific Intake)
1900.9; 2054.3
SECONDARY
Three Factor Eating Questionnaire (TFEQ) Restraint, Disinhibition and Hunger Subscales
SECONDARY
The Binge Eating Scale
SECONDARY
The Power of Food Scale
SECONDARY
The Dutch Eating Behaviour Questionnaire
SECONDARY
The Control of Eating Questionnaire

Summary

Food intake is mainly controlled through interactions between the gut and brain (the homeostatic control) and through our environment, with food exposure, mood and past experiences (the hedonic control) playing a major role. The link between the gut and the brain is mainly controlled through enteroendocrine cells (EC). These cells in the bowel sense nutrients in the food and link with the brain to control how much we eat. They make a number of hormones that link with the brain to control one's eating habits. Crohn's disease (CD) is an inflammatory disease of the bowel which can present with a number of symptoms including weight loss and loss of appetite. We thought some time ago that an increase in the number and function of these EC could play a central role. Since then we have carried out work which has shown that in CD these EC increase in number and produce more hormones after a meal. This finding could have a negative effect on food intake. This would be one explanation to the symptoms so commonly experienced by these patients. In CD we thus feel that there might be an imbalance in the appetite control. We expect an increasingly sensitive gut to food intake and a subdued mood and perception to food reward and that this imbalance will lead to a decrease in food reward and consequently a decrease in food intake. This study will be carried out using Healthy Volunteers and CD patients. We plan to measure food intake though telephone interviews and plan to analyse eating behaviour through 5 questionnaires.This study will help us to improve our understanding of what it is that controls food intake. This will be particularly important to patients with CD who routinely lose weight and appetite.

Eligibility Criteria

Inclusion Criteria

-

We will study a cohort of CD patients with active disease as defined by:

  • 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 or
  • C-Reactive protein >5mg/dl or,
  • Harvey-Bradshaw index score of 5-16
  • Body mass index (BMI) of 18-30.

For HV participants, inclusion criteria's 1 and 7 apply.

Exclusion Criteria

  • Present or recent (within 12 weeks) corticosteroid usage
  • Malignant disease
  • BMI 30.
  • 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
  • Severe CD where a delay in a change in medical treatment for 1 weeks would not be clinically advisable

For HV participants, all exclusion criteria apply with the exception of criteria no.12

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02379117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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