Nutrition and Clinical Outcomes in IBD
Recruiting · NCT06550310 · Observational (researchers observe without assigning treatment) · Lead sponsor: Barts & The London NHS Trust
View the official record on ClinicalTrials.gov →What this trial is about
The goal of this observational study is to demonstrate that nutritional status and body composition have an impact on clinical outcomes in inflammatory bowel disease (IBD). The main objectives are: 1. To compare the detection rates of undernutrition between a range of nutritional screening tools, physiological measures and assessment tools amongst patients with different IBD phenotypes 2. To correlate nutritional status, nutritional biomarkers and body composition with clinical outcomes in patients with IBD treated with advanced medical therapy or surgery 3. To determine a potential relationship between radiological muscle mass measurements and clinical outcomes in patients with IBD treated with advanced medical therapy or surgery Participants will undergo an assessment at pre-treatment baseline and then again at their scheduled follow-up. This is a non-interventional study and participants will not be required to have any invasive tests or hospital visits beyond that of standard clinical care.
Who can take part
Inclusion criteria
- Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) starting a new advanced medical therapy
- Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) undergoing an IBD-related surgery
- Age \>16
- Patients able and willing to provide written informed consent
Exclusion criteria
- Patients below the age of 16
- Patients who cannot provide informed consent
- Patients with a cardiac pacemaker or internal defibrillator
- Patients with active cancer and other disorders associated with severe cachexia
Where it is running
2 locations listed.
- Barts Health NHS Trust - London, United Kingdom
- Barts Health NHS Trust - London, United Kingdom