Eating Behaviour in Crohn's Disease
Launched by UNIVERSITY OF NOTTINGHAM · Feb 26, 2015
Trial Information
Current as of May 24, 2025
Completed
Keywords
ClinConnect Summary
STUDY BACKGROUND INFORMATION AND RATIONALE
Crohn's disease (CD) patients can present with a variety of luminal and extra-luminal symptoms but nutritional abnormalities are a very common but poorly studied \[1\] problem in this disease \[2\]. Apart from disease burden and repeated surgery, reduced appetite \[3\] and associated symptoms such as nausea undoubtedly contribute, with a major impact on quality of life.
Appetite and satiation, the processes by which a meal is terminated, involve complex interactions of homeostatic and hedonic factors. While the hypothalamus is central in the home...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • -
- We will study a cohort of CD patients with active disease as defined by:
- • 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 or
- • 5. C-Reactive protein \>5mg/dl or,
- • 6. Harvey-Bradshaw index score of 5-16
- • 7. Body mass index (BMI) of 18-30.
- • For HV participants, inclusion criteria's 1 and 7 apply.
- Exclusion Criteria:
- • 1. Present or recent (within 12 weeks) corticosteroid usage
- • 2. Malignant disease
- • 3. BMI \<18 or \>30.
- • 4. Significant cardiovascular or respiratory disease
- • 5. Diabetes mellitus
- • 6. Current Infection
- • 7. Neurological or cognitive impairment; significant physical disability
- • 8. Significant hepatic disease or renal failure
- • 9. 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) ,
- • 10. Subjects currently participating in (or in the last three months) any other research project
- • 11. pregnancy or breastfeeding or
- • 12. 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
About University Of Nottingham
The University of Nottingham is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses cutting-edge research and expert faculty to address pressing medical challenges. Through its dedicated clinical trials unit, the University of Nottingham conducts rigorous studies aimed at improving patient outcomes and contributing to the global body of medical knowledge. The institution prioritizes ethical practices and participant safety, ensuring that all trials are designed to uphold the highest standards of scientific integrity and regulatory compliance.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nottingham, Nottinghamshire, United Kingdom
Patients applied
Trial Officials
Gordon W Moran
Principal Investigator
University of Nottingham
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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