| NCT ID | NCT06550310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Barts & The London NHS Trust |
| Condition | Inflammatory Bowel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-10-24 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-10-24 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Shameer Mehta, MD
PRINCIPAL INVESTIGATOR
Barts & The London NHS Trust
Frequently Asked Questions
Who can join the NCT06550310 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06550310 currently recruiting?
Yes, NCT06550310 is actively recruiting participants. Contact the research team at sarah.faloon@nhs.net for enrollment information.
Where is the NCT06550310 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06550310 clinical trial?
NCT06550310 is sponsored by Barts & The London NHS Trust. The principal investigator is Shameer Mehta, MD at Barts & The London NHS Trust. The trial plans to enroll 300 participants.