Phase Angle as a New Possible Prognostic Factor in Chronic Intestinal Inflammatory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The correlation of phase angle with mucosal healing in patients with inflammatory bowel disease
研究概览
简要总结
Phase angle (PhA) is a biometric parameter measured by bioimpedance analysis (BIA), which reflects organism cellularity and tissues hydration. In addition, since it correlates with the presence of inflammation and the nutritional status, it could be useful to monitor inflammatory bowel disease (IBD) activity. The aim of this study was to establish the potential use of PhA as a new non-invasive and sensitive marker correlated with mucosal healing and/or IBD activity.
详细描述
Currently, fecal calprotectin is considered the best indirect marker inversely correlated with the mucosal healing in patients with inflammatory bowel disease (IBD). C reactive protein (CRP), is less reliable than fecal calprotectin in the evaluation of IBD activity. In order to establish the potential use of phase angle (PhA) as a new non-invasive and sensitive marker of mucosal healing and/or disease activity in patients with IBD, patients with diagnosis of chronic inflammatory bowel diseases (IBD) according to the European Crohn's and Colitis Organization (ECCO) guidelines will be enrolled. In these patients, the following parameters will be evaluated: age, sex, body mass index (BMI), percentage of weight loss in the last 6 months, duration of illness, location of disease, any previous intestinal surgery, ongoing therapy for IBD, activity disease by clinical scores, CRP, fecal calprotectin, disease activity by endoscopic scores, PhA and fat free mass (FFM).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histological report confirming the diagnosis of IBD,
- •value of C-reactive protein (CRP)
- •fecal calprotectin,
- •colonoscopy within 3 months from the enrollment.
排除标准
- •presence of ascites or edema,
- •chronic or autoimmune inflammatory diseases,
- •ongoing infections,
- •recent surgery (in the last 6 months),
- •neoplastic diseases,
- •ongoing enteral or parenteral nutrition,
- •presence of fistulae,
- •ileostomy or colostomy,
- •short bowel syndrome,
- •pregnancy or lactation.
结局指标
主要结局
The correlation of phase angle with mucosal healing in patients with inflammatory bowel disease
时间窗: At enrollment
The evaluation of phase angle (PhA), expressed in degrees, will be obtained by bioimpedenziometry, using a specific software (Bodygram Pro 3.0, Akern srl, Pontassieve, Italy). The assessment of mucosal healing will be performed by the following endoscopic scores: the Simple Endoscopic Score for Crohn's Disease (SES-CD) and the Mayo endoscopic score for Crohn's disease and Ulcerative Colitis (UC), respectively.
次要结局
- Evaluation of the presence of malnutrition by bioimpedance analysis(At enrollment)
研究者
Michele Barone
Associate Professor
University of Bari