Nutritional Assessment in Non-tuberculous Mycobacteria Pulmonary Disease: an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- BMI (body mass index)
研究概览
简要总结
Non-tuberculous mycobacterial (NTM) pulmonary disease (PD) is an emerging condition with heterogeneous manifestations from both the microbiological and the clinical point of view. Diagnostic and therapeutic guidelines are available but there are still unmet patients' and physicians' needs, including the exams to perform in the nutritional evaluation and intervention to improve health-related QoL and to control gastrointestinal side-effects during antimicrobial therapy, particularly in those with low body mass index and history of weight loss.
详细描述
The aim of the study is to evaluate the nutritional status in patients with non-tuberculous mycobacterial pulmonary disease (NTM-PD) and to provide an initial assessment of the potential impact of the introduction of targeted antibiotic therapy on the nutritional status itself.
Specifically, the primary objective is the assessment of the proportion of underweight subjects, i.e. with Body Mass Index (BMI) <18.5 kg/m2, to confirm that it is significantly higher than that of the general Italian population.
Study Design: Multicenter Cohort Pilot Observational Study
Participation in the study consists of two pneumological visits, as per normal clinical practice, (at the beginning of the study, T1, after 6 months, T3, and at the end of the antimicobacterial antibiotic therapy, T5) in which the collection of past medical history, measurement of oxygen saturation, pulmonary functional tests and 6-minute walking tests will be performed. In addition, nutritional assessments (T2, T4, T6) will be carried out at the same time as the pulmonary visits. Nutritional assessments will include anthropometric measurements, questionnaires on nutritional status and physical activity, performing blood chemistry tests, bioimpedance, dynamometry and gait speed 4 meters, to evaluate body composition and physical performance.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age greater than or equal to 18 years;
- •diagnosis of NTM-PD according to the BTS 2017 guidelines
排除标准
- •severe renal failure, defined as a GFR (glomerular filtration rate) lower than 30ml / min; NYHA class IV;
- •severe liver failure, defined as Child-Pugh score class C;
- •active solid or haematological neoplasms;
- •having already received (currently or in the prior 6 months) antimicobacterial therapy;
- •severe immunosuppression;
- •inability to walk without help;
- •need for oxygen therapy at rest;
- •participation in other interventional experimental protocols with use of a medicinal product.
结局指标
主要结局
BMI (body mass index)
时间窗: baseline (NTM-PD diagnosis)
kg/m2
次要结局
- Hand grip(baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up)
- Abdominal circumference(baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up)
- Mini Nutritional Assessment (MNA)(baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up)
- SMI (skeletal muscle mass index)(baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up)
- FFMI (fat free mass index)(baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up)
- BFMI (body fat mass index)(baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up)
- plasma vitamin D(baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up)
- Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST)(baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up)
研究者
Paola Faverio
Doctor
University of Milano Bicocca