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Search / Trial NCT02379117

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.

Locations

Nottingham, Nottinghamshire, United Kingdom

Patients applied

0 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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