Nutrition and Clinical Outcomes in IBD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorBarts & The London NHS Trust
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsSponsors and collaborators
Barts & The London NHS Trust
Lead sponsor
King's College London
Collaborator
Source ClinicalTrials.gov