Nutrition and Clinical Outcomes in IBD
NCT Number: NCT06550310
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Inflammatory Bowel Diseases|Crohn Disease|Ulcerative Colitis|Malnutrition|Sarcopenia
Sponsor: Barts & The London NHS Trust
Collaborators: King's College London
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2028-05

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.

Primary Outcome Measures: 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)., Clinical outcomes are as follows clinical response, clinical and biochemical remission, corticosteroid use, therapy switch or IBD related-surgery.

Clinical response in UC is defined as a ≥2-point and ≥30% decrease from baseline in partial Mayo score and a ≥1-point decrease from baseline in rectal bleeding sub-score or an absolute rectal bleeding sub-score ≤1. Clinical response in CD is defined as ≥ 3 points decrease of HBI score. Clinical remission is defined as a partial Mayo score of 0-1 in UC or HBI of ≤4 in CD. Biochemical remission is defined as faecal calprotectin \<200μg/mg and CRP ≤5mg/L., 14 and 52 weeks|Correlation of nutritional parameters (at baseline and during treatment) with pre-defined clinical outcomes in patients undergoing IBD-related surgery (at 30 and 90 days)., Clinical outcomes are defined as length of post-operative stay, formation of unplanned stoma, 30-day complication rate, 30-day complication grade (defined by the Clavien-Dindo scale) and 90-day readmission rate., 30 and 90 days
Secondary Outcome Measures: Correlation of currently used radiological muscle mass thresholds with pre-defined clinical outcomes in patients undergoing advanced medical therapy (at 14 and 52 weeks)., Clinical outcomes are as follows clinical response, clinical and biochemical remission, corticosteroid use, therapy switch or IBD related-surgery.

Clinical response in UC is defined as a ≥2-point and ≥30% decrease from baseline in partial Mayo score and a ≥1-point decrease from baseline in rectal bleeding sub-score or an absolute rectal bleeding sub-score ≤1. Clinical response in CD is defined as ≥ 3 points decrease of HBI score. Clinical remission is defined as a partial Mayo score of 0-1 in UC or HBI of ≤4 in CD. Biochemical remission is defined as faecal calprotectin \<200μg/mg and CRP ≤5mg/L., 14 and 52 weeks|Correlation of currently used radiological muscle mass thresholds with pre-defined clinical outcomes in patients undergoing advanced IBD-related surgery (at 30 and 90 days)., Clinical outcomes are defined as length of post-operative stay, formation of unplanned stoma, 30-day complication rate, 30-day complication grade (defined by the Clavien-Dindo scale) and 90-day readmission rate., 30 and 90 days