Nutrition and Body Composition and Association With Clinical Outcomes in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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:
- 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
- To correlate nutritional status, nutritional biomarkers and body composition with clinical outcomes in patients with IBD treated with advanced medical therapy or surgery
- 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.
详细描述
Background and Rationale:
Inflammatory bowel disease (IBD) comprises Crohn's disease (CD) and ulcerative colitis (UC). It affects nearly 400,000 people in the United Kingdom (UK) and the global prevalence is rising. Many patients suffer an impaired quality of life. Whilst advanced medical therapies are being used more often, the lifetime risk of surgery is as high as 70%. Unfortunately, loss of response to medical therapies and post-operative complications remain major clinical challenges. Risk factors for adverse treatment outcomes include disease duration, emergency surgery and undernutrition. Not only is undernutrition a risk factor for adverse clinical outcomes, it is present in up to 36% of patients with IBD. Crucially, unlike other risk factors, it is also modifiable with cheap and safe interventions. It therefore presents an ideal opportunity for intervention. Despite this, current methods of detecting undernutrition in IBD are unfit for purpose.
Body composition (BC) analysis is emerging as a highly clinically relevant physiological marker in IBD. Skeletal muscle loss with functional impairment (sarcopenia) in IBD patients is associated with a range of outcomes including disease flares, hospitalisation, need for surgery and need for ICU admissions. Radiological measurement of skeletal muscle index (SMI) at the level of the 3rd lumbar vertebra is objective and reproducible. Validated software designed specifically for this purpose (Slice-o-Matic [Tomovision, Canada]) can be used on CT/MRI scans which are often performed as part of standard IBD care. However, despite this, BC analysis by any method is not performed in routine clinical practice. The most commonly used physiological markers in the UK remain weight and body mass index (BMI), which do not provide any measure of BC.
Overall, there remains uncertainty over which nutritional tools should be used in patients with IBD. Most studies have been small, retrospective and heterogenous. No study has performed a comparative analysis of more than three measurements in the same patient cohort. Evidence of the ability of widely used nutritional screening tools to identify IBD patients most at risk of adverse clinical outcomes is lacking. Finally, there is little data describing the performance of different tools and measures according to disease phenotype and disease activity. This study proposes to meet this knowledge gap by comparing a range of nutritional tools in a large, prospective, well-phenotyped IBD cohort.
Study design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Patients able and willing to provide written informed consent
排除标准
- •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
研究组 & 干预措施
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)
Surgical treatment group
Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) undergoing an IBD-related surgery
结局指标
主要结局
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).
时间窗: 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.
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).
时间窗: 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.
次要结局
- Correlation of currently used radiological muscle mass thresholds with pre-defined clinical outcomes in patients undergoing advanced medical therapy (at 14 and 52 weeks).(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).(30 and 90 days)