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Nutrition and Clinical Outcomes in IBD

Study acronym: NUTRICO-IBD
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary completion date: Dec 2028 to May 2028
    • Start date changed from estimate of Sep 2025 to Oct 24, 2024
    v4
  2. Primary completion date: Dec 2027 to Dec 2028
    • Start date: Sep 2024 to Sep 2025
    • Study completion date: May 2028 to Dec 2028
    v3
  3. Primary endpoints revised (2)
    • Secondary endpoints revised (2)
    • Study description shortened, about 1 word
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06550310
Lead Sponsor Barts & The London NHS Trust
Collaborators: King's College London
Conditions
(from sponsor)		 Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Malnutrition, Sarcopenia
Related terms Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases, Malnutrition, Sarcopenia
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov