Nutrition and Clinical Outcomes in IBD

Sponsor
Barts & The London NHS Trust
Study ID
NCT06550310
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 13, 2024
Start date
Oct 24, 2024
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Medical treatment group
    Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) starting a new advanced medical therapy (e.g. biologic or small molecule)
  • Arm: Surgical treatment group
    Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) undergoing an IBD-related surgery

Primary Outcome Measure

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). [ Time Frame: 14 and 52 weeks ]

Central Contacts

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