NL-OMON52907招募中不适用
The effect of targeted nutrient supplementation on physical activity and health related quality of life in COPD - NUTRECOVER trial
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 198 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 198
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •COPD patients NUTRECOVER trial:
- •- COPD patients with moderate to very severe disease stage according to GOLD
- •criteria (i.e. GOLD stage II-IV);
- •- Medically stable in the opinion of the investigator.
- •Reference group microbiome study:
- •- Lung function: FEV1/FVC > 0.7
- •- Medically stable in the opinion of the investigator.
排除标准
- •COPD patients NUTRECOVER trial:
- •Exclusion criteria indicated with an asterisk (*) are also exclusion criteria
- •for the subjects in the reference group for the microbiome study.
- •- Age <18 years;*
- •- Allergy or intolerance to components of the study product;
- •- Investigator*s uncertainty about the willingness or ability of the patient to
- •comply with the protocol requirements (e.g. leg amputation) or patients
- •suffering from other acute or unstable chronic diseases that will compromise
- •the study outcome (e.g. active cancer requiring treatment);*
- •- Participation in any other study involving investigational or marketed
- •products concomitantly or within four weeks prior to entry into the study;*
- •- Patients with terminal illness;*
- •- Recent hospital admission (<4 weeks prior to the start of the study);*
- •- COPD patients with temporary oral steroid or antibiotics use due to a COPD
- •exacerbation in the last 4 weeks or subjects in the reference group with
- •antibiotics use for any reason in the last 4 weeks;
- •- Lung malignancy in the previous 5 years;*
- •- Diagnosis of dementia or neurodegenerative disease (e.g., Alzheimer*s
- •disease, Parkinson*s disease, Huntington*s chorea, frontotemporal dementia) in
- •the medical records;*
- •- Recent diagnosis of cerebral conditions (< 1 year e.g. cerebral infarction,
- •hemorrhage, brain tumors, transient ischemic attack) in the medical records;*
- •- Any medical condition that significantly interferes with digestion and/or
- •gastro-intestinal function (e.g. short bowel syndrome, inflammatory bowel
- •disease, gastric ulcers, gastritis, (gastro)-enteritis, GI cancer as judged by
- •the investigator;*
- •-Subjects in the reference group in the microbiome study: diagnosis of any
- •chronic lung disease.
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