How nutrition and body composition relate to outcomes in people with IBD
Nutrition and Body Composition and Association With Clinical Outcomes in Inflammatory Bowel Disease
This study will see if nutrition and muscle mass affect outcomes in people with Crohn's disease or ulcerative colitis who are starting advanced medicines or having IBD-related surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Barts & The London NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06550310 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort study that measures nutritional status, nutritional biomarkers, and body composition in people with IBD at baseline before starting advanced medical therapy or undergoing IBD-related surgery and again at scheduled follow-up. The study compares detection rates of undernutrition across several screening tools, physiological measures, and assessment instruments. It also correlates radiological muscle mass measurements (including lumbar skeletal muscle index) and other body composition markers with clinical outcomes such as treatment response, complications, and hospitalisation. No experimental treatments are given and assessments are limited to procedures done as part of standard clinical care.
Who should consider this trial
Good fit: Adults aged over 16 with Crohn's disease, ulcerative colitis, or IBD-unclassified who are about to start a new advanced medical therapy or undergo IBD-related surgery and can provide written informed consent.
Not a fit: People under 16, those unable to give consent, patients with active cancer or severe cachexia, and those with contraindicated implants like pacemakers or internal defibrillators are excluded and would not be expected to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help identify patients at higher risk who might benefit from targeted nutritional or muscle-preserving interventions to reduce complications and improve recovery.
How similar studies have performed: Previous observational studies have linked low muscle mass and poor nutritional status to worse IBD outcomes, but standardized screening tools and radiological measures have not been widely validated in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London
- Barts Health NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Shameer Mehta, MD — Barts & The London NHS Trust
- Study coordinator: Sarah Faloon, MBChB
- Email: sarah.faloon@nhs.net
- Phone: 07713444631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.