Nutrition and Clinical Outcomes in IBD
Observational · No treatment assigned · 1 site · Barts & The London NHS Trust
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 16 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 300 participants are expected to take part.
- Start date: 2024-10-24.
- Main results expected around 2028-05 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United Kingdom.
Main thing being measured
- Correlation of nutritional parameters (at baseline and during treatment) with pre-defined clinical outcomes in patients undergoing advanced medical therapy (at 14 and 52 weeks). (14 and 52 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Malnutrition; Sarcopenia |
| Lead sponsor | Barts & The London NHS Trust |
| Collaborators | King's College London |
| Enrollment | 300 (estimated) |
| Start date | 2024-10-24 |
| Primary completion (est.) | 2028-05 |
| First posted | 2024-08-13 |
| Last updated | 2026-02-19 |
| Official title | Nutrition and Body Composition and Association With Clinical Outcomes in Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT06550310 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Barts Health NHS Trust | London | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.